FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFANT APNEA MONITOR
K Number: K802710
·
Decision Nov 12, 1980
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
15
Applicant Total
2
Review Days
12
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Basic Information
- Device Name
- INFANT APNEA MONITOR
- K Number
- K802710
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2377
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Douglas Scientific Products
- Date Received
- October 31, 1980
- Decision Date
- November 12, 1980
- Product Code
- FLS
- 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 |
|---|---|---|---|
| FLS | Monitor, Apnea, Facility Use | FDA class 2 | Anesthesiology |
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Other Clearances by Douglas Scientific Products
| K Number | Device Name | ||
|---|---|---|---|
| K813174 | BRADYCARDIA ALARM | Jan 22, 1982 | Substantially Equivalent |