The following data is part of a premarket notification filed by Bracco Diagnostic, Inc. with the FDA for Bracco Diagnostics Inc. Protoco, L Touch Colon Insufflator.
| Device ID | K132192 |
| 510k Number | K132192 |
| Device Name: | BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Applicant | BRACCO DIAGNOSTIC, INC. 259 PROSPECT PLAINS ROAD BUILDING H Monroe Township, NJ 08831 |
| Contact | Tracey Alexander |
| Correspondent | Tracey Alexander BRACCO DIAGNOSTIC, INC. 259 PROSPECT PLAINS ROAD BUILDING H Monroe Township, NJ 08831 |
| Product Code | FCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-15 |
| Decision Date | 2014-02-14 |
| Summary: | summary |