FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
PNEUPAC PARAPAC PLUS
K Number: K123957
·
Decision Sep 16, 2013
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
99
Applicant Total
3
Review Days
269
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PNEUPAC PARAPAC PLUS
- K Number
- K123957
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5925
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Smiths Medical International , Ltd.
- Date Received
- December 21, 2012
- Decision Date
- September 16, 2013
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTL), ordered by most recent decision date.
VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
FDA 510(k)
FDA Class 2
·Anesthesiology
Oxymag - Transport and Emergency Ventilator
FDA 510(k)
FDA Class 2
·Anesthesiology
VORTRAN GO2VENT with PEEP Valve
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag
FDA 510(k)
FDA Class 2
·Anesthesiology
Puffin Lite Infant Resuscitation System
FDA 510(k)
FDA Class 2
·Anesthesiology
SafeT T-Piece Resuscitator
FDA 510(k)
FDA Class 2
·Anesthesiology