The following data is part of a premarket notification filed by Consolidated Research Of Richmond, Inc with the FDA for Zmachine, Model Dt-100.
| Device ID | K101830 |
| 510k Number | K101830 |
| Device Name: | ZMACHINE, MODEL DT-100 |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | CONSOLIDATED RESEARCH OF RICHMOND, INC 26250 EUCLID AVE SUITE 024 Euclid, OH 44132 |
| Contact | Richard Kaplan |
| Correspondent | Richard Kaplan CONSOLIDATED RESEARCH OF RICHMOND, INC 26250 EUCLID AVE SUITE 024 Euclid, OH 44132 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-01 |
| Decision Date | 2011-03-31 |
| Summary: | summary |