FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYSTEM ONE HYPERBARIC CHAMBER
K Number: K951044
·
Decision Jan 25, 1996
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
68
Applicant Total
1
Review Days
324
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Basic Information
- Device Name
- SYSTEM ONE HYPERBARIC CHAMBER
- K Number
- K951044
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5470
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nth Systems, Inc.
- Date Received
- March 7, 1995
- Decision Date
- January 25, 1996
- 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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