FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONITOR HS8
K Number: K782044
·
Decision Jan 10, 1979
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
2
Review Days
33
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Basic Information
- Device Name
- MONITOR HS8
- K Number
- K782044
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Scientific & General Pty. , Ltd.
- Date Received
- December 8, 1978
- Decision Date
- January 10, 1979
- Product Code
- BZQ
- 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 |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | FDA class 2 | Anesthesiology |
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Other Clearances by Scientific & General Pty. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K782045 | MONITOR HS7 | Jan 10, 1979 | Substantially Equivalent |