FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PENLON PPV VAPORIZER
K Number: K844007
·
Decision Mar 12, 1985
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
56
Applicant Total
10
Review Days
151
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Basic Information
- Device Name
- PENLON PPV VAPORIZER
- K Number
- K844007
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Penlon, Inc.
- Date Received
- October 12, 1984
- Decision Date
- March 12, 1985
- Product Code
- CAD
- 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 |
|---|---|---|---|
| CAD | Vaporizer, Anesthesia, Non-Heated | FDA class 2 | Anesthesiology |
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Other Clearances by Penlon, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K936046 | SIGMA ELITE | Nov 4, 1994 | Substantially Equivalent |
| K902381 | PENLON BREATHING SYSTEM PRESSURE MONITOR | Aug 17, 1990 | Substantially Equivalent |
| K894689 | PENLON IDP PRESSURE FAILURE ALARM | Aug 10, 1989 | Substantially Equivalent |
| K844008 | PENLON AM1000 ANAESTHESIA MACHINE | Mar 12, 1985 | Substantially Equivalent |
| K823555 | MAGTARAK RESPIRATORY MONITOR & FLOW SENS | Jan 5, 1983 | Substantially Equivalent |
| K803052 | NUFFIELD ANESTHESIA VENTILATOR SER. 400 | Jan 7, 1981 | Substantially Equivalent |
| K801253 | CREST ELECTRONIC WARMING BLANKET | Jan 2, 1981 | Substantially Equivalent |
| K801254 | PENLON I.D.P. PRESSSURE FAILURE ALARM | Jun 9, 1980 | Substantially Equivalent |
| K801255 | PENLON JUMBO CARBON DIOXIDE ABSORBER | Jun 4, 1980 | Substantially Equivalent |