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 |