FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLOMETER
K Number: K781541
·
Decision Sep 26, 1978
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
23
Applicant Total
4
Review Days
18
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Basic Information
- Device Name
- FLOMETER
- K Number
- K781541
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2340
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Chemetron Medical Products, Inc.
- Date Received
- September 8, 1978
- Decision Date
- September 26, 1978
- Product Code
- CAX
- 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 |
|---|---|---|---|
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | FDA class 1 | Anesthesiology |
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