510(k) K101988

HEAL FORCE CO2 INCUBATOR by Shanghai Lishen Scientific Equipment Co., Ltd. — Product Code MQG

K101988 is an FDA 510(k) premarket notification submitted by Shanghai Lishen Scientific Equipment Co., Ltd. for the device "HEAL FORCE CO2 INCUBATOR". The FDA issued a decision of Substantially Equivalent on February 8, 2011. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2011
Date Received
July 14, 2010
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