The following data is part of a premarket notification filed by Algotek, Inc. with the FDA for Algo I.
| Device ID | K852687 |
| 510k Number | K852687 |
| Device Name: | ALGO I |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | ALGOTEK, INC. 805 VETERANS BLVD. Redwood City, CA 94063 |
| Contact | Liverani |
| Correspondent | Liverani ALGOTEK, INC. 805 VETERANS BLVD. Redwood City, CA 94063 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-25 |
| Decision Date | 1985-09-18 |