FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
T CLASS HYPERBARIC FACILITIES
K Number: K954387
·
Decision Dec 15, 1995
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
68
Applicant Total
5
Review Days
118
Basic Information
- Device Name
- T CLASS HYPERBARIC FACILITIES
- K Number
- K954387
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5470
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- REIMERS SYSTEMS, INC.
- Date Received
- August 19, 1995
- Decision Date
- December 15, 1995
- 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 |
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