FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERCEPTOR COMPENSATOR MORSE MANIFOLD
K Number: K951722
·
Decision Mar 25, 1996
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
147
Applicant Total
8
Review Days
346
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Basic Information
- Device Name
- PERCEPTOR COMPENSATOR MORSE MANIFOLD
- K Number
- K951722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2850
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Namic
- Date Received
- April 14, 1995
- Decision Date
- March 25, 1996
- Product Code
- DRS
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | FDA class 2 | Cardiovascular |
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Other Clearances by Namic
| K Number | Device Name | ||
|---|---|---|---|
| K953676 | BREEZE DIGITAL INFLATION DEVICE | Mar 29, 1996 | Substantially Equivalent |
| K921322 | MORSE ANESTHESIA MANIFOLD | Jul 9, 1993 | Substantially Equivalent |
| K822100 | HIGH PRESSURE CONTRAST INJECTION LINE | Aug 24, 1982 | Substantially Equivalent |
| K813549 | CONTINUOUS FLUSH DEVICE | Jan 12, 1982 | Substantially Equivalent |
| K790083 | CATHETER, ARTERIAL LINE | Jan 25, 1979 | Substantially Equivalent |
| K790082 | ARTERIAL EXTENSION SET | Jan 25, 1979 | Substantially Equivalent |
| K782095 | STOPCOCKS, MANIFOLDS | Jan 23, 1979 | Substantially Equivalent |