GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03
FDA 510(k) clearance K013731 · decided 2001-11-27
Clearance details
- K-number
- K013731
- Device name
- GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03
- Applicant
- Gimmi GmbH
- Decision
- Substantially Equivalent
- Date received
- 2001-11-09
- Decision date
- 2001-11-27
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Amsterdam, Nh, NL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Gimmi GmbH
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.