The following data is part of a premarket notification filed by Beam-med Ltd with the FDA for Beammed Sunlight Miniomni Bone Sonometer.
| Device ID | K110646 |
| 510k Number | K110646 |
| Device Name: | BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER |
| Classification | Bone Sonometer |
| Applicant | BEAM-MED LTD 8 HALAPID STR. Petach Tikva, IL 49170 |
| Contact | Rita Koremblum |
| Correspondent | Rita Koremblum BEAM-MED LTD 8 HALAPID STR. Petach Tikva, IL 49170 |
| Product Code | MUA |
| CFR Regulation Number | 892.1180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-04 |
| Decision Date | 2011-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290012704109 | K110646 | 000 |