The following data is part of a premarket notification filed by Geomed Medizin-technik Gmbh & Co. with the FDA for Assisto Arm Systems.
| Device ID | K052745 |
| 510k Number | K052745 |
| Device Name: | ASSISTO ARM SYSTEMS |
| Classification | Endoscope, Neurological |
| Applicant | GEOMED MEDIZIN-TECHNIK GMBH & CO. AMSTEL 320-I Amsterdam, NL 1017ap |
| Contact | Angelika Scherp |
| Correspondent | Angelika Scherp GEOMED MEDIZIN-TECHNIK GMBH & CO. AMSTEL 320-I Amsterdam, NL 1017ap |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-30 |
| Decision Date | 2005-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M2746208051 | K052745 | 000 |
| M2746208041 | K052745 | 000 |
| M274620EC8001 | K052745 | 000 |
| M2746208001 | K052745 | 000 |