FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESPIGRAPH
K Number: K854956
·
Decision Mar 20, 1986
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
6
Review Days
99
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Basic Information
- Device Name
- RESPIGRAPH
- K Number
- K854956
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1850
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Respitrace Corp.
- Date Received
- December 11, 1985
- Decision Date
- March 20, 1986
- Product Code
- BZK
- 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 |
|---|---|---|---|
| BZK | Spirometer, Monitoring (W/Wo Alarm) | FDA class 2 | Anesthesiology |
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Other Clearances by Respitrace Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K852692 | RESPITRACE 300SC | Jul 15, 1985 | Substantially Equivalent |
| K823780 | RESPITRACE 300SC | Jan 20, 1984 | Substantially Equivalent |
| K823783 | RESPICOMB | Jan 11, 1984 | Substantially Equivalent |
| K823782 | RESPITRACE SYSTEM | Mar 7, 1983 | Substantially Equivalent |
| K772016 | RESPITRACE | Jan 26, 1978 | Substantially Equivalent |