FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROKONICS SENTRY MODEL 8500
K Number: K851819
·
Decision Jan 21, 1986
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
2
Review Days
270
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Basic Information
- Device Name
- ROKONICS SENTRY MODEL 8500
- K Number
- K851819
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Rokonics, Inc.
- Date Received
- April 26, 1985
- Decision Date
- January 21, 1986
- 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 Rokonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K871576 | ROKONICS 8500 | Jul 16, 1987 | Substantially Equivalent |