The following data is part of a premarket notification filed by Progeny, Inc. with the FDA for Preva, 76in Arm, 66in Arm, 56in Arm, Models P7017, P7016, P7015.
| Device ID | K043092 |
| 510k Number | K043092 |
| Device Name: | PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | PROGENY, INC. 1407 BARCLAY BLVD. Buffalo Grove, IL 60089 |
| Contact | Alan Krema |
| Correspondent | Alan Krema PROGENY, INC. 1407 BARCLAY BLVD. Buffalo Grove, IL 60089 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-09 |
| Decision Date | 2004-12-13 |
| Summary: | summary |