FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFECYCLE AEROBIC MONITOR 123
K Number: K840488
·
Decision May 30, 1984
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
171
Applicant Total
1
Review Days
114
Basic Information
- Device Name
- LIFECYCLE AEROBIC MONITOR 123
- K Number
- K840488
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- HEART RATE, INC.
- Date Received
- February 6, 1984
- Decision Date
- May 30, 1984
- 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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