FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MATRX HOPE(R) 5 RESUSCITATOR
K Number: K921982
·
Decision Oct 28, 1994
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
207
Applicant Total
14
Review Days
913
Basic Information
- Device Name
- MATRX HOPE(R) 5 RESUSCITATOR
- K Number
- K921982
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MATRIX MEDICA, INC.
- Date Received
- April 28, 1992
- Decision Date
- October 28, 1994
- 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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