The following data is part of a premarket notification filed by Commwell Ltd. with the FDA for Physioglove Es With Ecg Analysis.
| Device ID | K103791 |
| 510k Number | K103791 |
| Device Name: | PHYSIOGLOVE ES WITH ECG ANALYSIS |
| Classification | Electrocardiograph |
| Applicant | COMMWELL LTD. RECHOV YAD HARUTZIM 4 Kfar Saba, IL 44641 |
| Contact | Irving Levy |
| Correspondent | Irving Levy COMMWELL LTD. RECHOV YAD HARUTZIM 4 Kfar Saba, IL 44641 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-27 |
| Decision Date | 2011-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290012672064 | K103791 | 000 |