FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE
K Number: K921978
·
Decision Nov 17, 1992
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
77
Applicant Total
3
Review Days
203
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Basic Information
- Device Name
- BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE
- K Number
- K921978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Core-M, Inc.
- Date Received
- April 28, 1992
- Decision Date
- November 17, 1992
- 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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