AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
FDA 510(k) clearance K973985 · decided 1998-10-30
Clearance details
- K-number
- K973985
- Device name
- AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
- Applicant
- Datex-Engstrom, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-20
- Decision date
- 1998-10-30
- Days to decision
- 375 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Tewksbury, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Datex-Engstrom
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.