510(k) K101988
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