The following data is part of a premarket notification filed by Agency For Medical Innovations Gmbh with the FDA for Easyinstruments.
| Device ID | K182013 |
| 510k Number | K182013 |
| Device Name: | EasyInstruments |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Agency For Medical Innovations GmbH Im Letten 1 Feldkirch, AT 6800 |
| Contact | Martin Hohlrieder |
| Correspondent | Pierre Bounaud Acknowledge Regulatory Strategies, LLC 2251 San Diego Ave., Suite B-257 San Diego, CA 92110 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-27 |
| Decision Date | 2019-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EAMIEAH10100 | K182013 | 000 |
| EAMIECM10111 | K182013 | 000 |
| EAMIEDI10200 | K182013 | 000 |
| EAMIEDI10311 | K182013 | 000 |
| EAMIEDI10511 | K182013 | 000 |
| EAMIEDM10100 | K182013 | 000 |
| EAMIEDM10111 | K182013 | 000 |
| EAMIEFG10100 | K182013 | 000 |
| EAMIEFG10111 | K182013 | 000 |
| EAMIEIH10100 | K182013 | 000 |
| EAMIEIR13100 | K182013 | 000 |
| EAMIECM10100 | K182013 | 000 |
| EAMIECI10311 | K182013 | 000 |
| EAMIEAS13100 | K182013 | 000 |
| EAMIEAS13200 | K182013 | 000 |
| EAMIEAS15100 | K182013 | 000 |
| EAMIEAS15200 | K182013 | 000 |
| EAMIEAS15300 | K182013 | 000 |
| EAMIECA10200 | K182013 | 000 |
| EAMIECA10300 | K182013 | 000 |
| EAMIECA10400 | K182013 | 000 |
| EAMIECA11100 | K182013 | 000 |
| EAMIECI10201 | K182013 | 000 |
| EAMIEIR13200 | K182013 | 000 |
| EAMIEIR15100 | K182013 | 000 |
| EAMIEIR15200 | K182013 | 000 |
| EAMIESI11511 | K182013 | 000 |
| EAMIESI12101 | K182013 | 000 |
| EAMIESI13100 | K182013 | 000 |
| EAMIESI13200 | K182013 | 000 |
| EAMIESI15100 | K182013 | 000 |
| EAMIESI15200 | K182013 | 000 |
| EAMIESI15300 | K182013 | 000 |
| EAMIESM10100 | K182013 | 000 |
| EAMIESM10111 | K182013 | 000 |
| EAMIEVI10100 | K182013 | 000 |
| EAMIESI11400 | K182013 | 000 |
| EAMIESI11311 | K182013 | 000 |
| EAMIEIR15300 | K182013 | 000 |
| EAMIERH10100 | K182013 | 000 |
| EAMIESF10111 | K182013 | 000 |
| EAMIESG10111 | K182013 | 000 |
| EAMIESH13100 | K182013 | 000 |
| EAMIESH13200 | K182013 | 000 |
| EAMIESH15100 | K182013 | 000 |
| EAMIESH15200 | K182013 | 000 |
| EAMIESH15300 | K182013 | 000 |
| EAMIESI11200 | K182013 | 000 |
| EAMIEVI10111 | K182013 | 000 |