The following data is part of a premarket notification filed by Consolidated Research Of Richmond, Inc. Dba General Sleep Co with the FDA for Zmachine Synergy.
| Device ID | K172986 |
| 510k Number | K172986 |
| Device Name: | Zmachine Synergy |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | Consolidated Research Of Richmond, Inc. Dba General Sleep Co 26250 Euclid Avenue, Suite 709 Cleveland, OH 44132 |
| Contact | Richard Kaplan |
| Correspondent | Richard Kaplan Consolidated Research Of Richmond, Inc. Dba General Sleep Co 26250 Euclid Avenue, Suite 709 Cleveland, OH 44132 |
| Product Code | OLV |
| Subsequent Product Code | MNR |
| Subsequent Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2017-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B5663000010 | K172986 | 000 |