FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER
K Number: K082455
·
Decision May 22, 2009
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
68
Applicant Total
3
Review Days
269
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER
- K Number
- K082455
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5470
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gulf Coast Hyperbarics, Inc.
- Date Received
- August 26, 2008
- Decision Date
- May 22, 2009
- Product Code
- CBF
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CBF | Chamber, Hyperbaric | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CBF), ordered by most recent decision date.
FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber
FDA 510(k)
FDA Class 2
·Anesthesiology
Revitalair 430+
FDA 510(k)
FDA Class 2
·Anesthesiology
Revitalair 430F
FDA 510(k)
FDA Class 2
·Anesthesiology
OxyHeal 4000 Multiplace Hyperbaric Chamber Family
FDA 510(k)
FDA Class 2
·Anesthesiology
Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
FDA 510(k)
FDA Class 2
·Anesthesiology
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
FDA 510(k)
FDA Class 2
·Anesthesiology