FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM
K Number: K983648
·
Decision Feb 24, 1999
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
68
Applicant Total
4
Review Days
131
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Basic Information
- Device Name
- SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM
- K Number
- K983648
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5470
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Perry Baromedical Services
- Date Received
- October 16, 1998
- Decision Date
- February 24, 1999
- 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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