The following data is part of a premarket notification filed by Bracco Diagnostic, Inc. with the FDA for Bracco Diagnostics Inc. Co2 Endoscopic Insufflator In Line Tubing Set.
| Device ID | K123047 |
| 510k Number | K123047 |
| Device Name: | BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Applicant | BRACCO DIAGNOSTIC, INC. 107 COLLEGE ROAD Princeton, NJ 08540 |
| Contact | Tracey Alexander |
| Correspondent | Tracey Alexander BRACCO DIAGNOSTIC, INC. 107 COLLEGE ROAD Princeton, NJ 08540 |
| Product Code | FCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2013-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765013134 | K123047 | 000 |
| 10816765013127 | K123047 | 000 |
| 10816765013073 | K123047 | 000 |
| 10724995180420 | K123047 | 000 |
| 10724995180413 | K123047 | 000 |
| 10724995180406 | K123047 | 000 |