The following data is part of a premarket notification filed by Nexcore Technology, Llc with the FDA for Nexcore Gi Insufflator.
Device ID | K162332 |
510k Number | K162332 |
Device Name: | Nexcore GI Insufflator |
Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
Applicant | NEXCORE TECHNOLOGY, LLC P.O. Box 903 Winchester, MA 01890 |
Contact | Julie Broderick |
Correspondent | Olaf Teichert TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
Product Code | FCX |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2016-08-19 |
Decision Date | 2016-09-29 |
Summary: | summary |