The following data is part of a premarket notification filed by Planer Plc with the FDA for Planer Bt37 Incubator.
| Device ID | K121566 |
| 510k Number | K121566 |
| Device Name: | PLANER BT37 INCUBATOR |
| Classification | Accessory, Assisted Reproduction |
| Applicant | PLANER PLC 15696 OAKSTAND ROAD Poway, CA 92064 -3389 |
| Contact | Eric Gruff |
| Correspondent | Eric Gruff PLANER PLC 15696 OAKSTAND ROAD Poway, CA 92064 -3389 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-29 |
| Decision Date | 2012-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B199GDBT37WWORIGIO0 | K121566 | 000 |
| B199GDBT37USORIGIO0 | K121566 | 000 |
| B199GDBT3701ORIGIO0 | K121566 | 000 |