Pan-America Hyperbarics, Hyperbaric Chamber System, Model PAH-M10+2
FDA 510(k) K021689 · Pan-America Hyperbarics, Inc.
510(k) numberK021689
Submission
- Device name
- Pan-America Hyperbarics, Hyperbaric Chamber System, Model PAH-M10+2
- Applicant
- Pan-America Hyperbarics, Inc.
San Antonio, TX, US - Received
- May 23, 2002
- Decision date
- October 24, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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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| K140559 | Sechrist Monoplace Hyperbaric Oxygen ChamberCBF · Special | Sechrist Industries, Inc. | 05/30/2014SE |
| K102831 | Rsi 4200CBF · Abbreviated | Reimers Systems, Inc. | 08/19/2011SE |
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| 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 |
|---|---|---|
| K122560 | Versalvent Model V1 Hyperbaric Chamber Ventilator Model V1CBK · Traditional | 03/26/2013SE |
| K021693 | Pan-America Hyperbarics Hyperbaric Chamber System, Model PAH-S1CBF · Abbreviated | 10/24/2002SE |
| K021690 | Pan-America Hyperbarics Hyperbaric Chamber System, Model PAH-M3+1CBF · Abbreviated | 10/24/2002SE |
Questions and answers
When was Pan-America Hyperbarics, Hyperbaric Chamber System, Model PAH-M10+2 cleared by the FDA?
Pan-America Hyperbarics, Hyperbaric Chamber System, Model PAH-M10+2 (K021689) received a 510(k) decision of Substantially Equivalent on October 24, 2002, 154 days after the submission was received.
What is the product code of K021689?
The FDA product code is CBF – Chamber, Hyperbaric, a Class II (moderate risk) device regulated under 21 CFR 868.5470.