OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD
FDA 510(k) clearance K925580 · decided 1993-06-02
Clearance details
- K-number
- K925580
- Device name
- OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD
- Applicant
- Ohmeda Anesthesia Systems Therapy Group
- Decision
- Substantially Equivalent
- Date received
- 1992-11-04
- Decision date
- 1993-06-02
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Madison, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec recall (Z-2161-2013) | GE Healthcare, LLC | 2013-09-06 |