PLANER BT37 INCUBATOR— 510(k) K121566
Substantially EquivalentPlaner Plc
FDA 510(k) clearance K121566 for PLANER BT37 INCUBATOR, Substantially Equivalent on 2012-11-29. Applicant: Planer Plc. Device class: 2.
Clearance details
- Applicant
- Planer Plc
- Product code
- Code MQG
- Device class
- Class 2
- Regulation
- 21 CFR 884.6120
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poway, CA, US
Recent devices under product code MQG
view all- K261083 — Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)
- K260194 — Vacuum Pump (Model: AD-VPUM-500)
- K242684 — Harioculture TL-16 Time-lapse Incubator
- K232493 — Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
- K180188 — Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
More clearances from Planer Plc
view allRecalls naming K121566
K-number listed on FDA's recall record- Z-1822-2022 — 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 can also be used with the BT37 Mark II Benchtop Incubator.
- Z-1823-2022 — Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark II Benchtop Incubator (AY200246)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121566.
Data sourced from openFDA. This site is unofficial and independent of the FDA.