The following data is part of a premarket notification filed by Hds Medical, Inc. with the FDA for Ttm5000 Telephonic Ekg Monitor.
| Device ID | K973267 |
| 510k Number | K973267 |
| Device Name: | TTM5000 TELEPHONIC EKG MONITOR |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | HDS MEDICAL, INC. 2 FAIRE WINDS Languna Niguel, CA 92677 |
| Contact | Semih Cirit |
| Correspondent | Semih Cirit HDS MEDICAL, INC. 2 FAIRE WINDS Languna Niguel, CA 92677 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-29 |
| Decision Date | 1998-01-29 |
| Summary: | summary |