FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGLE USE MANUAL RESUSCITATORS
K Number: K905002
·
Decision Mar 29, 1991
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
208
Applicant Total
3
Review Days
142
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Basic Information
- Device Name
- SINGLE USE MANUAL RESUSCITATORS
- K Number
- K905002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Custom Medical, Inc.
- Date Received
- November 7, 1990
- Decision Date
- March 29, 1991
- 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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