Models MR700/MR720/MR730 Dual Servo Resp Humid Acc
FDA 510(k) K913368 · Fisher & Paykel Electronics , Ltd.
510(k) numberK913368
Submission
- Device name
- Models MR700/MR720/MR730 Dual Servo Resp Humid Acc
- Applicant
- Fisher & Paykel Electronics , Ltd.
Auckland, New Zealand, NZ - Received
- July 24, 1991
- Decision date
- January 13, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5450
- Specialty
- Anesthesiology
Other 510(k)s with product code BTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262268 | Optiflow Oxygen Kit (AA484J)BTT · Special | Fisher and Paykel Healthcare Limited | 08/27/2026SE |
| K254078 | HVT 2.0BTT · Traditional | Vapotherm, Inc. | 04/13/2026SE |
| K251448 | FL-10000U Respiratory HumidifierBTT · Traditional | Flexicare Medical Limited. | 01/16/2026SE |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/14/2026SE |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)BTT · Special | Fisher & Paykel Healthcare, Ltd. | 12/19/2025SE |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | Medline Industries, LP | 07/02/2025SE |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special | Fisher & Paykel Healthcare, Ltd. | 06/25/2025SE |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional | Laboratorios Biogalenic S.A. DE C.V. | 01/30/2025SE |
| K241778 | Hudson RCI Comfort Flo® CubCannulaBTT · Traditional | Medline Industries, LP | 12/19/2024SE |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional | Medline Industries, LP | 09/27/2024SE |
More from Medline Industries, LP
| 510(k) | Device | Decision |
|---|---|---|
| K973161 | CPAP Humidifier (HC 200)BZD · Traditional | 07/10/1998SE |
| K972885 | Servo-Control Wall-Mount Cosycot Infant Warmer Model IW960, Manual Control Wall-Mount…FMT · Traditional | 10/30/1997SE |
| K971695 | Servo-Control Cosycot Infant Warmer, Manual-Control Cosycot Infant WarmerFMT · Traditional | 07/28/1997SE |
| K971461 | Servo-Control Wall-Mount Infant WARMER(IW980)/MANUAL-CONTROL Wall-Mount Infant…FMT · Traditional | 07/16/1997SE |
| K970432 | Infant Radiant Warmer - Models IW910 and IW920FMT · Traditional | 05/07/1997SE |
| K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)BTT · Traditional | 03/12/1996SE |
| K953711 | Air Entrainer 900RT008BZR · Traditional | 11/08/1995SE |
| K953949 | Humidifier & AccessoriesCAW · Traditional | 10/16/1995SE |
| K934140 | MR290 Humidification Chamber Single UseBTT · Traditional | 01/24/1994SE |
| K924234 | Cons. Current Periph. Nerve Loc. NS232,NS262,NS272KOI · Traditional | 05/27/1993SE |
Questions and answers
When was Models MR700/MR720/MR730 Dual Servo Resp Humid Acc cleared by the FDA?
Models MR700/MR720/MR730 Dual Servo Resp Humid Acc (K913368) received a 510(k) decision of Substantially Equivalent on January 13, 1992, 173 days after the submission was received.
What is the product code of K913368?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.