Gamow Bag, Hyper Oxy, Hyper Oxy P/T, Pressure-Cizer
FDA 510(k) K001409 · Hyperbaric Technologies, Inc.
510(k) numberK001409
Submission
- Device name
- Gamow Bag, Hyper Oxy, Hyper Oxy P/T, Pressure-Cizer
- Applicant
- Hyperbaric Technologies, Inc.
Mccordsville, IN, US - Received
- May 4, 2000
- Decision date
- August 2, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBF – Chamber, Hyperbaric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5470
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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|---|---|---|---|
| K240569 | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberCBF · Traditional | Fink Engineering Pty, Ltd. | 11/21/2024SE |
| K220290 | Revitalair 430+CBF · Traditional | Us Hyperbaric Network | 05/04/2023SE |
| K171899 | Revitalair 430FCBF · Traditional | Oxavita Srl | 11/22/2019SE |
| K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyCBF · Special | Oxyheal Medical Systems, Inc. | 03/22/2017SE |
| K152223 | Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control…CBF · Traditional | Oxyheal Medical Systems, Inc. | 04/29/2016SE |
| K140559 | Sechrist Monoplace Hyperbaric Oxygen ChamberCBF · Special | Sechrist Industries, Inc. | 05/30/2014SE |
| K102831 | Rsi 4200CBF · Abbreviated | Reimers Systems, Inc. | 08/19/2011SE |
| K092991 | O.S.C.A.R. (Operating System for Control and Record Keeping)CBF · Traditional | Environmental Tectonics Corp. | 08/13/2010SE |
| K101262 | Flexi-LiteCBF · Traditional | Pressure-Tech, Inc. | 06/10/2010SE |
| K100268 | Sechrist Monoplace Hyperbaric Oxygen ChamberCBF · Special | Sechrist Industries, Inc. | 04/26/2010SE |
More from Sechrist Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K011866 | Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 SeriesCBF · Abbreviated | 06/06/2002SE |
Questions and answers
When was Gamow Bag, Hyper Oxy, Hyper Oxy P/T, Pressure-Cizer cleared by the FDA?
Gamow Bag, Hyper Oxy, Hyper Oxy P/T, Pressure-Cizer (K001409) received a 510(k) decision of Substantially Equivalent on August 2, 2000, 90 days after the submission was received.
What is the product code of K001409?
The FDA product code is CBF – Chamber, Hyperbaric, a Class II (moderate risk) device regulated under 21 CFR 868.5470.