FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
PATIENT VALVE WITH AIR ENTRAINMENT
K Number: K863410
·
Decision Jan 12, 1987
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
99
Applicant Total
19
Review Days
173
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Basic Information
- Device Name
- PATIENT VALVE WITH AIR ENTRAINMENT
- K Number
- K863410
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5925
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Pneupac , Ltd.
- Date Received
- July 23, 1986
- Decision Date
- January 12, 1987
- Product Code
- BTL
- 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 |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | FDA class 2 | Anesthesiology |
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Other Clearances by Pneupac , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K040090 | COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS) | May 27, 2004 | Substantially Equivalent |
| K030803 | PARAPAC 200D TRANSPORT, MODEL V200D | Sep 29, 2003 | Substantially Equivalent |
| K021841 | COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER | Jul 17, 2003 | Substantially Equivalent |
| K020899 | PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D | Dec 13, 2002 | Substantially Equivalent |
| K960515 | PARAPAC | Oct 10, 1996 | Substantially Equivalent |
| K862830 | MODELS 2R AND 3R PNEUPAC VENTILATOR/RESUSCITATOR | Oct 15, 1986 | Substantially Equivalent |
| K843737 | PNEUPAC INSTANT ACTION VENTILATOR/RESUS | Oct 4, 1984 | Substantially Equivalent |
| K832700 | PNEU PAC VENTILATOR/RESUSCITATORS | Nov 14, 1983 | Substantially Equivalent |
| K820220 | VENTILATOR MODELS | Feb 18, 1982 | Substantially Equivalent |
| K792453 | PNEUPAC OXYGEN THERAPY UNIT | Feb 5, 1980 | Substantially Equivalent |