FLOWMETER NIPPLE ADAPTOR
FDA 510(k) clearance K934945 · decided 1993-11-17
Clearance details
- K-number
- K934945
- Device name
- FLOWMETER NIPPLE ADAPTOR
- Applicant
- Cardio-Search , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-13
- Decision date
- 1993-11-17
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- CCN
- Device class
- 1
- Regulation number
- 868.2300
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Dundas, Ont.L9h 5y2, Canada, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OXYGEN FLOW CONTROLLER (K920783) | Puritan Bennett Corp. | 1992-09-18 |
| NEB-U-VENT (K872038) | Design Technologies, Inc. | 1987-08-10 |
| MODIFIED NOFLO I (K871262) | Design Technologies, Inc. | 1987-07-21 |
| NO-FLO I (K863613) | Design Technologies, Inc. | 1986-12-15 |
| OXYGEN CONSERVATOR (K863657) | Salter Labs | 1986-10-15 |
| FLOW INTERRUPTION INDICATOR (K863659) | Salter Labs | 1986-10-15 |
| BORDON GAGE REGULATOR #BG (K823775) | Timeter Instrument Corp. | 1983-01-14 |
| VITAMIN B12 FOLATE RADIOASSAY (K802037) | Corning Medical & Scientific | 1980-11-21 |
Recalls involving this device
No recalls on record reference this clearance.