FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POSIVAC
K Number: K791127
·
Decision Jul 30, 1979
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
42
Applicant Total
75
Review Days
42
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Basic Information
- Device Name
- POSIVAC
- K Number
- K791127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5430
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Vital Signs, Inc.
- Date Received
- June 18, 1979
- Decision Date
- July 30, 1979
- Product Code
- CBN
- 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 |
|---|---|---|---|
| CBN | Apparatus, Gas-Scavenging | FDA class 2 | Anesthesiology |
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| K001553 | BREAS PV 100 CPAP SYSTEM | Aug 3, 2000 | Substantially Equivalent |
| K000441 | BODYGUARD | Apr 11, 2000 | Substantially Equivalent |
| K994044 | CLEEN-ABLE | Feb 25, 2000 | Substantially Equivalent |
| K990412 | CUFF-ABLE PLUS | Sep 1, 1999 | Substantially Equivalent |