COOK MINI-INCUBATOR— 510(k) K983642
Substantially EquivalentCook Ob/Gyn
FDA 510(k) clearance K983642 for COOK MINI-INCUBATOR, Substantially Equivalent on 1999-02-01. Applicant: Cook Ob/Gyn. Device class: 2.
Clearance details
- Applicant
- Cook Ob/Gyn
- 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
- Spencer, IN, 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 Cook Ob/Gyn
view all- K062438 — BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
- K030441 — SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
- K023850 — SYDNEY IVF EMBRYO BIOPSY MEDIUM
- K013597 — TAMPONADE UTERINE BALLOON CATHETER SET
- K002385 — COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
Recalls naming K983642
K-number listed on FDA's recall record- Z-0809-2021 — Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
- Z-1377-2018 — MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
- Z-1378-2018 — MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983642.
Data sourced from openFDA. This site is unofficial and independent of the FDA.