The following data is part of a premarket notification filed by Heramed Ltd. with the FDA for Herabeat™ Us.
| Device ID | K191110 |
| 510k Number | K191110 |
| Device Name: | HeraBEAT™ US |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | HeraMED Ltd. 6 Meir Ariel St. Netanya, IL 4059300 |
| Contact | Dganit Litinsky |
| Correspondent | Sheila Hemeon-heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 91002 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-26 |
| Decision Date | 2019-11-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17290111520126 | K191110 | 000 |