510(k) K823899
K823899 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "INFANT CARE SYSTEM". The FDA issued a decision of Substantially Equivalent on Apr 14, 1983. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Narco Scientific has 29 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 14, 1983
- Date Received
- Dec 27, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type
- 510(k)