FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BREATH TRACKER
K Number: K892942
·
Decision Jun 23, 1989
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
77
Applicant Total
3
Review Days
63
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Basic Information
- Device Name
- BREATH TRACKER
- K Number
- K892942
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Core-M, Inc.
- Date Received
- April 21, 1989
- Decision Date
- June 23, 1989
- Product Code
- CAP
- 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 |
|---|---|---|---|
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | FDA class 2 | Anesthesiology |
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