510(k) K133742
K133742 is an FDA 510(k) premarket notification submitted by At Medical Uab for the device "XQ-1 INCUBATOR". The FDA issued a decision of Substantially Equivalent on April 23, 2014. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120. At Medical Uab has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2014
- Date Received
- December 9, 2013
- 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