FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EASY BREATHER MODEL 100 ACCESSORIES
K Number: K902300
·
Decision Jul 19, 1990
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
20
Applicant Total
4
Review Days
57
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Basic Information
- Device Name
- EASY BREATHER MODEL 100 ACCESSORIES
- K Number
- K902300
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5935
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Progressive Productions , Ltd.
- Date Received
- May 23, 1990
- Decision Date
- July 19, 1990
- Product Code
- BYT
- 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 |
|---|---|---|---|
| BYT | Ventilator, External Body, Negative Pressure, Adult (Cuirass) | FDA class 2 | Anesthesiology |
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