Devilbiss Model 9200D Heated Humidifier System
FDA 510(k) K020900 · Sunrise Medical Hhg, Inc.
510(k) numberK020900
Submission
- Device name
- Devilbiss Model 9200D Heated Humidifier System
- Applicant
- Sunrise Medical Hhg, Inc.
Somerset, PA, US - Received
- March 20, 2002
- Decision date
- June 3, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
Device classification
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5450
- Specialty
- Anesthesiology
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| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K083249 | Quickie RhythmITI · Special | 12/23/2008SE |
| K012437 | Devilbiss Sleep Recorder Model # RM60MNR · Traditional | 07/16/2002SE |
| K020329 | Devilbiss PD1000NFB · Traditional | 06/19/2002SE |
| K011229 | Devilbiss 9000 Series CPAP, Model 9001BZD · Special | 07/11/2001SE |
| K003626 | Devilbiss HumidifierBTT · Traditional | 05/04/2001SE |
| K993492 | Devilbiss Nebulizer Model 800CAF · Traditional | 04/21/2000SE |
| K991722 | Devilbiss 5 Liter Oxygen ConcentratorCAW · Traditional | 11/03/1999SE |
| K982304 | Devilbiss Suction UnitJCX · Traditional | 09/25/1998SE |
| K981602 | Devilbiss Model 6305D Heavy Duty Ac AspiratorBTA · Traditional | 07/17/1998SE |
Questions and answers
When was Devilbiss Model 9200D Heated Humidifier System cleared by the FDA?
Devilbiss Model 9200D Heated Humidifier System (K020900) received a 510(k) decision of Substantially Equivalent on June 3, 2002, 75 days after the submission was received.
What is the product code of K020900?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.