FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VENTILATORY FREQUENCY MONITOR
K Number: K834569
·
Decision Mar 30, 1984
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
3
Review Days
92
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Basic Information
- Device Name
- VENTILATORY FREQUENCY MONITOR
- K Number
- K834569
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Cryo Corp.
- Date Received
- December 29, 1983
- Decision Date
- March 30, 1984
- Product Code
- BZO
- 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 |
|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | FDA class 1 | Anesthesiology |
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