FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESPIRONICS' DIGITAL MANOMETER
K Number: K904935
·
Decision Apr 3, 1991
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
77
Applicant Total
172
Review Days
153
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Basic Information
- Device Name
- RESPIRONICS' DIGITAL MANOMETER
- K Number
- K904935
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Respironics, Inc.
- Date Received
- November 1, 1990
- Decision Date
- April 3, 1991
- 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 |
Similar 510(k) Clearances
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