Bay Area Hypersciences
FDA 510(k) K030713 · Bay Area Hypersciences, LLC
510(k) numberK030713
Submission
- Device name
- Bay Area Hypersciences
- Applicant
- Bay Area Hypersciences, LLC
Houston, TX, US - Received
- March 6, 2003
- Decision date
- December 19, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code CBF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
Questions and answers
When was Bay Area Hypersciences cleared by the FDA?
Bay Area Hypersciences (K030713) received a 510(k) decision of Substantially Equivalent on December 19, 2003, 288 days after the submission was received.
What is the product code of K030713?
The FDA product code is CBF – Chamber, Hyperbaric, a Class II (moderate risk) device regulated under 21 CFR 868.5470.