510(k) K132543
K132543 is an FDA 510(k) premarket notification submitted by Bistos Co., Ltd. for the device "INFANT INCUBATOR". The FDA issued a decision of Substantially Equivalent on July 3, 2014. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Bistos Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 2014
- Date Received
- August 13, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Incubator, Neonatal
- Device Class
- Class II
- Regulation Number
- 880.5400
- Review Panel
- HO
- Submission Type