The following data is part of a premarket notification filed by Rocket Medical Plc with the FDA for Embryon Ultrasound Needle Guide.
| Device ID | K032015 |
| 510k Number | K032015 |
| Device Name: | EMBRYON ULTRASOUND NEEDLE GUIDE |
| Classification | Needle, Assisted Reproduction |
| Applicant | ROCKET MEDICAL PLC WEAR INDUSTRIAL ESTATE DISTRICT 6 Washington, Tyne & Wear, GB Ne38 9bz |
| Contact | Tracy Charlton |
| Correspondent | Tracy Charlton ROCKET MEDICAL PLC WEAR INDUSTRIAL ESTATE DISTRICT 6 Washington, Tyne & Wear, GB Ne38 9bz |
| Product Code | MQE |
| CFR Regulation Number | 884.6100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-30 |
| Decision Date | 2003-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055270971593 | K032015 | 000 |
| 05055270988553 | K032015 | 000 |
| 05055270988645 | K032015 | 000 |
| 05055270956781 | K032015 | 000 |
| 05055270935397 | K032015 | 000 |
| 05055270935403 | K032015 | 000 |
| 05055270935410 | K032015 | 000 |
| 05055270935427 | K032015 | 000 |
| 05055270964625 | K032015 | 000 |
| 05055270966032 | K032015 | 000 |
| 05055270966063 | K032015 | 000 |
| 05055270966094 | K032015 | 000 |
| 05055270966131 | K032015 | 000 |
| 05055270967473 | K032015 | 000 |
| 05055270971258 | K032015 | 000 |
| 05055270984296 | K032015 | 000 |