The following data is part of a premarket notification filed by Gimmi Gmbh with the FDA for Gimmi Alpha Sinuscopes Model # E.8282.01/31/71 + E.8284.01/31/71; Gimmi Alpha Bronchoscopes Model # E.8189.00/01/02/03.
| Device ID | K013731 |
| 510k 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 |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | GIMMI GMBH AMSTEL 320-I Amsterdam, NL 1017ap |
| Contact | Dagmar S Maser |
| Correspondent | Dagmar S Maser GIMMI GMBH AMSTEL 320-I Amsterdam, NL 1017ap |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-09 |
| Decision Date | 2001-11-27 |
| Summary: | summary |