MODEL IW17.5A INTRA OPERATIVE TRANSDUCER
FDA 510(k) clearance K904665 · decided 1991-01-11
Clearance details
- K-number
- K904665
- Device name
- MODEL IW17.5A INTRA OPERATIVE TRANSDUCER
- Applicant
- Kretztechnik AG
- Decision
- Substantially Equivalent
- Date received
- 1990-10-15
- Decision date
- 1991-01-11
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Austria, AT
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kretztechnik AG
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.
Recalls involving this device
No recalls on record reference this clearance.