The following data is part of a premarket notification filed by Integrated Surgical Systems, Inc. with the FDA for Frameless Neuromate.
| Device ID | K991081 |
| 510k Number | K991081 |
| Device Name: | FRAMELESS NEUROMATE |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | INTEGRATED SURGICAL SYSTEMS, INC. 1850 RESEARCH PARK DR. Davis, CA 95616 |
| Contact | R.d. Hibbert |
| Correspondent | R.d. Hibbert INTEGRATED SURGICAL SYSTEMS, INC. 1850 RESEARCH PARK DR. Davis, CA 95616 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-31 |
| Decision Date | 1999-06-25 |
| Summary: | summary |