AIRSTRIP OB
FDA 510(k) clearance K090061 · decided 2009-01-23
Clearance details
- K-number
- K090061
- Device name
- AIRSTRIP OB
- Applicant
- Airstrip Technologies, LP
- Decision
- Substantially Equivalent
- Date received
- 2009-01-09
- Decision date
- 2009-01-23
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- HGM
- Device class
- 2
- Regulation number
- 884.2740
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- San Antonio, TX, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Airstrip Technologies
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.