Hme-Booster
FDA 510(k) K990614 · King Systems Corp.
510(k) numberK990614
Submission
- Device name
- Hme-Booster
- Applicant
- King Systems Corp.
Noblesville, IN, US - Received
- February 25, 1999
- Decision date
- May 23, 2000
- 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
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| K021634 | King LT, Models # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105CAE · Traditional | 01/09/2003SE |
| K012485 | MS-140 All-Round Enhanced Performance Filter; MS-141 All-Round Enhanced Performance…CAH · Traditional | 10/09/2001SE |
| K010040 | Sleeved FilterCAH · Traditional | 03/09/2001SE |
| K983817 | Breathing Circuit Bacterial Filter/Heat and Moisture Exchanger (Hme/F)CAH · Traditional | 03/01/1999SE |
| K973797 | Breathing Circuit Bacterial FilterCAH · Traditional | 03/12/1998SE |
| K953513 | Xenon CircuitIYT · Traditional | 11/03/1995SE |
| K951093 | Kab SystemBSF · Traditional | 03/24/1995SE |
| K950318 | Flex BlueCBH · Traditional | 02/13/1995SE |
Questions and answers
When was Hme-Booster cleared by the FDA?
Hme-Booster (K990614) received a 510(k) decision of Substantially Equivalent on May 23, 2000, 453 days after the submission was received.
What is the product code of K990614?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.