PARAPAC— 510(k) K960515
Substantially EquivalentPneupac , Ltd.
FDA 510(k) clearance K960515 for PARAPAC, Substantially Equivalent on 1996-10-10. Applicant: Pneupac , Ltd.. Device class: 2.
Clearance details
- Applicant
- Pneupac , Ltd.
- Product code
- Code BTL
- Device class
- Class 2
- Regulation
- 21 CFR 868.5925
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Luton Beds Lu2 Oah, GB
Recent devices under product code BTL
view allMore clearances from Pneupac , Ltd.
view all- K040090 — COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS)
- K030803 — PARAPAC 200D TRANSPORT, MODEL V200D
- K021841 — COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER
- K020899 — PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D
- K863410 — PATIENT VALVE WITH AIR ENTRAINMENT
Adverse events under product code BTL
product code BTL- Death
- 8
- Malfunction
- 3,256
- Other
- 1
- Total
- 3,265
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.