FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
AUTOLINK BODY PLETHYSMOGRAPH
K Number: K960121
·
Decision Jan 9, 1997
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
89
Applicant Total
4
Review Days
364
Basic Information
- Device Name
- AUTOLINK BODY PLETHYSMOGRAPH
- K Number
- K960121
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- P.K. MORGAN LTD.
- Date Received
- January 11, 1996
- Decision Date
- January 9, 1997
- Product Code
- BZC
- 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 |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | FDA class 2 | Anesthesiology |
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