FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
SIMPLIFY COMPACT RESUSCITATOR
K Number: K021716
·
Decision Oct 8, 2002
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
208
Applicant Total
1
Review Days
138
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
- SIMPLIFY COMPACT RESUSCITATOR
- K Number
- K021716
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Polymed (Xiamen) Plastic Industrial Co., Ltd.
- Date Received
- May 23, 2002
- Decision Date
- October 8, 2002
- Product Code
- BTM
- 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 |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTM), ordered by most recent decision date.
The BAG manual resuscitator and accessories
FDA 510(k)
FDA Class 2
·Anesthesiology
butterflyBVM
FDA 510(k)
FDA Class 2
·Anesthesiology
EOlife®
FDA 510(k)
FDA Class 2
·Anesthesiology
Sotair Device
FDA 510(k)
FDA Class 2
·Anesthesiology
Disposable Manual Resuscitator
FDA 510(k)
FDA Class 2
·Anesthesiology
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
FDA 510(k)
FDA Class 2
·Anesthesiology