FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
FLOWMETER NIPPLE ADAPTOR
K Number: K934945
·
Decision Nov 17, 1993
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
8
Applicant Total
1
Review Days
35
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Basic Information
- Device Name
- FLOWMETER NIPPLE ADAPTOR
- K Number
- K934945
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2300
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cardio-Search , Ltd.
- Date Received
- October 13, 1993
- Decision Date
- November 17, 1993
- Product Code
- CCN
- 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 |
|---|---|---|---|
| CCN | Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge | FDA class 1 | Anesthesiology |
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