FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL
K Number: K850029
·
Decision Apr 29, 1985
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
9
Applicant Total
38
Review Days
115
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Basic Information
- Device Name
- UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL
- K Number
- K850029
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2620
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Utah Medical Products, Inc.
- Date Received
- January 4, 1985
- Decision Date
- April 29, 1985
- Product Code
- BXX
- 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 |
|---|---|---|---|
| BXX | Calibrator, Pressure, Gas | FDA class 1 | Anesthesiology |
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