Home / 510(k) Clearances / K011327

510(k) K011327

DB1 EMBRYO FREEZE by Zander Medical Supplies, Inc. — Product Code MQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2002
Date Received
May 1, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6120
Review Panel
OB
Submission Type

Other clearances by Zander Medical Supplies, Inc.

  • K041952 — ZIVF-AIRE (September 8, 2005)
  • K002971 — MTG - MINITUB HEATED STAGE SYSTEMS (December 15, 2000)
  • K002961 — MINITUB MULTI-PURPOSE CASSETTES (November 21, 2000)
  • K003184 — RS BIOTECH GALAXY 'R' CO2 INCUBATOR (November 20, 2000)

Other clearances for product code MQG

  • K242684 — Harioculture TL-16 Time-lapse Incubator (May 22, 2025)
  • K232493 — Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) (May 7, 2024)
  • K180188 — Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish (June 7, 2018)
  • K173264 — EmbryoScope+ (May 11, 2018)
  • K180304 — Geri Embryo Incubator and Geri Dish (April 20, 2018)
  • K171736 — Geri Embryo Incubator and Geri Dish (November 15, 2017)
  • K160753 — COOK Vacuum Pump (June 13, 2017)
  • K160504 — RI Witness Embryology Heated Plate (July 18, 2016)
  • K151357 — MIRI TL (April 22, 2016)
  • K133712 — EMBRYOVIEWER SOFTWARE (August 8, 2014)