The following data is part of a premarket notification filed by Research Instruments Limited with the FDA for Ri Witness Embryology Heated Plate.
| Device ID | K160504 |
| 510k Number | K160504 |
| Device Name: | RI Witness Embryology Heated Plate |
| Classification | Accessory, Assisted Reproduction |
| Applicant | RESEARCH INSTRUMENTS LIMITED BICKLAND INDUSTRIAL PARK Falmouth, GB Tr11 4ta |
| Contact | Wendy Hassan |
| Correspondent | Wendy Hassan RESEARCH INSTRUMENTS LIMITED BICKLAND INDUSTRIAL PARK Falmouth, GB Tr11 4ta |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-24 |
| Decision Date | 2016-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060488041532 | K160504 | 000 |
| 05060488041525 | K160504 | 000 |
| 05060170185834 | K160504 | 000 |