The following data is part of a premarket notification filed by Clincal Instruments Corp. with the FDA for Tweetheart #102 Fetal/neonatal Heartbeat Annunciat.
| Device ID | K852704 |
| 510k Number | K852704 |
| Device Name: | TWEETHEART #102 FETAL/NEONATAL HEARTBEAT ANNUNCIAT |
| Classification | System, Monitoring, Perinatal |
| Applicant | CLINCAL INSTRUMENTS CORP. 1717 SUPERIOR AVE. Cleveland, OH 44114 |
| Contact | Lewis I Schwartz |
| Correspondent | Lewis I Schwartz CLINCAL INSTRUMENTS CORP. 1717 SUPERIOR AVE. Cleveland, OH 44114 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-26 |
| Decision Date | 1985-11-26 |