The following data is part of a premarket notification filed by Medical Devices (pvt) Ltd. with the FDA for Ophthalmoscopes Diagnostic Instrument Kits.
| Device ID | K131719 |
| 510k Number | K131719 |
| Device Name: | OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | MEDICAL DEVICES (PVT) LTD. WAZIRABAD RD. Ugoki-sialkot, PK Pk |
| Contact | Tauseef Ajmal |
| Correspondent | Tauseef Ajmal MEDICAL DEVICES (PVT) LTD. WAZIRABAD RD. Ugoki-sialkot, PK Pk |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-12 |
| Decision Date | 2013-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889483042250 | K131719 | 000 |
| 10889483042236 | K131719 | 000 |
| 10889483042212 | K131719 | 000 |
| 10889483007471 | K131719 | 000 |
| 10889483003206 | K131719 | 000 |
| 10889483003190 | K131719 | 000 |