OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD— 510(k) K925580
Substantially EquivalentOhmeda Anesthesia Systems Therapy Group
FDA 510(k) clearance K925580 for OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD, Substantially Equivalent on 1993-06-02. Applicant: Ohmeda Anesthesia Systems Therapy Group. Device class: 2.
Clearance details
- Applicant
- Ohmeda Anesthesia Systems Therapy Group
- Product code
- Code BSZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5160
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Madison, WI, US
Recent devices under product code BSZ
view allMore clearances from Ohmeda Anesthesia Systems Therapy Group
view allAdverse events under product code BSZ
product code BSZ- Death
- 23
- Injury
- 298
- Malfunction
- 32,987
- Total
- 33,308
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K925580
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K925580.
Data sourced from openFDA. This site is unofficial and independent of the FDA.