FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STRYKER PRESSURE MONITOR SYSTEM
K Number: K883485
·
Decision Sep 13, 1988
Classifications
1
FEI Numbers
398
Registration Numbers
398
Same Product Code
22
Applicant Total
124
Review Days
28
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Basic Information
- Device Name
- STRYKER PRESSURE MONITOR SYSTEM
- K Number
- K883485
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Stryker Corp.
- Date Received
- August 16, 1988
- Decision Date
- September 13, 1988
- Product Code
- FTY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FTY | Tape, Measuring, Rulers And Calipers | FDA class 1 | General, Plastic Surgery |
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