FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PORTABLE PNEUMATIC CALIBRATOR 65-150
K Number: K780981
·
Decision Aug 2, 1978
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
9
Applicant Total
6
Review Days
49
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Basic Information
- Device Name
- PORTABLE PNEUMATIC CALIBRATOR 65-150
- K Number
- K780981
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2620
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Pennwalt Corp.
- Date Received
- June 14, 1978
- Decision Date
- August 2, 1978
- Product Code
- BXX
- 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 |
|---|---|---|---|
| BXX | Calibrator, Pressure, Gas | FDA class 1 | Anesthesiology |
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Other Clearances by Pennwalt Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K833241 | INTREX | Oct 28, 1983 | Substantially Equivalent |
| K801860 | S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX | Oct 10, 1980 | Substantially Equivalent |
| K801274 | S.S. WHITE-PENNWALT PRELUDE PIT SEALANT | Jun 9, 1980 | Substantially Equivalent |
| K800133 | PANOREX II DENTAL X-RAY UNIT | Mar 3, 1980 | Substantially Equivalent |
| K800063 | XR-710 | Mar 3, 1980 | Substantially Equivalent |