FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXYLATOR EM-100
K Number: K944349
·
Decision Apr 17, 1995
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
99
Applicant Total
1
Review Days
223
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Basic Information
- Device Name
- OXYLATOR EM-100
- K Number
- K944349
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5925
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cpr Medical Devices, Inc.
- Date Received
- September 6, 1994
- Decision Date
- April 17, 1995
- 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 |
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