The following data is part of a premarket notification filed by Given Imaging Ltd. with the FDA for Bravo Ph Monitoring System And Accessories.
| Device ID | K102543 |
| 510k Number | K102543 |
| Device Name: | BRAVO PH MONITORING SYSTEM AND ACCESSORIES |
| Classification | Electrode, Ph, Stomach |
| Applicant | GIVEN IMAGING LTD. P.O. BOX 258 NEW INDUSTRIAL PARK Yoqneam, IL 20692 |
| Contact | Tim Thomas |
| Correspondent | Tim Thomas GIVEN IMAGING LTD. P.O. BOX 258 NEW INDUSTRIAL PARK Yoqneam, IL 20692 |
| Product Code | FFT |
| CFR Regulation Number | 876.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-03 |
| Decision Date | 2010-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290101366393 | K102543 | 000 |
| 07290101361282 | K102543 | 000 |
| 07290101361299 | K102543 | 000 |
| 07290101361688 | K102543 | 000 |
| 07290101361695 | K102543 | 000 |
| 07290101363064 | K102543 | 000 |
| 07290101364283 | K102543 | 000 |
| 07290101364771 | K102543 | 000 |
| 07290101365303 | K102543 | 000 |
| 07290110361068 | K102543 | 000 |