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 |