FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MANUAL PULMONARY RESUSICITATOR
K Number: K953546
·
Decision Feb 29, 1996
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
208
Applicant Total
13
Review Days
216
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Basic Information
- Device Name
- MANUAL PULMONARY RESUSICITATOR
- K Number
- K953546
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Marketing Concepts
- Date Received
- July 28, 1995
- Decision Date
- February 29, 1996
- 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 |
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FDA 510(k)
FDA Class 2
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Other Clearances by Medical Marketing Concepts
| K Number | Device Name | ||
|---|---|---|---|
| K982215 | MANUAL RESUSCITATOR WITH ACE | Sep 18, 1998 | Substantially Equivalent |
| K961867 | PEEP VALVE | Aug 13, 1996 | Substantially Equivalent |
| K961330 | BAGRIGHT INFANT RESUSCITATOR | Jul 2, 1996 | Substantially Equivalent |
| K961329 | BAGRIGHT CHILD RESUSCITATOR | Jul 2, 1996 | Substantially Equivalent |
| K961369 | BAGRIGHT RESPOSABLE RESUSCITATOR | Jun 28, 1996 | Substantially Equivalent |
| K961332 | BAGRIGHT RESPOSABLE INFANT RESUSCITATOR | Jun 28, 1996 | Substantially Equivalent |
| K961331 | BAGRIGHT RESPOSABLE CHILD RESUSCITATOR | Jun 28, 1996 | Substantially Equivalent |
| K961868 | RESPOSABLE CHILD RESUSCITATOR | Jun 28, 1996 | Substantially Equivalent |
| K961882 | RESPOSABLE INFANT RESUSCITATOR | Jun 28, 1996 | Substantially Equivalent |
| K954296 | BAGRIGHT RESUSCITATOR | Dec 20, 1995 | Substantially Equivalent |