The following data is part of a premarket notification filed by Medrobotics Corporation with the FDA for Medrobotics Flex System.
| Device ID | K150776 |
| 510k Number | K150776 |
| Device Name: | Medrobotics Flex System |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | MEDROBOTICS CORPORATION 475 PARAMOUNT DRIVE Raynham, MA 02767 |
| Contact | John D Bonasera |
| Correspondent | John D Bonasera MEDROBOTICS CORPORATION 475 PARAMOUNT DRIVE Raynham, MA 02767 |
| Product Code | EOB |
| Subsequent Product Code | EOX |
| Subsequent Product Code | GCI |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-24 |
| Decision Date | 2015-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850190004018 | K150776 | 000 |
| 00850190004537 | K150776 | 000 |
| 00850190004544 | K150776 | 000 |
| 00850190004551 | K150776 | 000 |
| 00850190004568 | K150776 | 000 |
| 00850190004711 | K150776 | 000 |
| 01108501900047 | K150776 | 000 |
| 00908501900044 | K150776 | 000 |
| 01208501900044 | K150776 | 000 |
| 00850190004520 | K150776 | 000 |
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| 00850190004155 | K150776 | 000 |
| 00850190004025 | K150776 | 000 |
| 00850190004032 | K150776 | 000 |
| 00850190004049 | K150776 | 000 |
| 00850190004070 | K150776 | 000 |
| 00850190004087 | K150776 | 000 |
| 00850190004094 | K150776 | 000 |
| 00850190004117 | K150776 | 000 |
| 00850190004124 | K150776 | 000 |
| 20850190004197 | K150776 | 000 |
| 01508501900045 | K150776 | 000 |
| 05508501900041 | K150776 | 000 |
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| 00708501900040 | K150776 | 000 |
| 00208501900045 | K150776 | 000 |
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| 07108501900041 | K150776 | 000 |
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| 05908501900049 | K150776 | 000 |
| 06008501900045 | K150776 | 000 |
| 06108501900042 | K150776 | 000 |
| 00508501900046 | K150776 | 000 |