510(k) K121566 ยท MQG Accessory, Assisted Reproduction
PLANER BT37 INCUBATOR
| Applicant | Planer Plc, Poway CA, US |
| Decision | Substantially Equivalent, Nov 29, 2012 |
| Received | May 29, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121566
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2022 | CooperSurgical, Inc. Humidifier bottle and syringe filter kit (6 count of each) for the BT37
Mark I Benchtop Incubator (AY102295).
The Mark I model is no longer produced, but the legacy humidifier
bottle component design Open, Classified |
MQG | None listed |
| Sep 28, 2022 | CooperSurgical, Inc. Humidifier bottle and syringe filter kit (6 count of each) for the BT37
Mark II Benchtop Incubator (AY200246) Open, Classified |
MQG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.