The following data is part of a premarket notification filed by Bracco Diagnostic, Inc. with the FDA for Bracco Diagnostics, Inc. Co2mpact Endodcopic Insufflator.
| Device ID | K111648 |
| 510k Number | K111648 |
| Device Name: | BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Applicant | BRACCO DIAGNOSTIC, INC. 532 BROADHOLLOW ROAD SUITE 126 Melville, NY 11747 |
| Contact | Tracey Alexander |
| Correspondent | Tracey Alexander BRACCO DIAGNOSTIC, INC. 532 BROADHOLLOW ROAD SUITE 126 Melville, NY 11747 |
| Product Code | FCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-13 |
| Decision Date | 2011-11-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816765013103 | K111648 | 000 |
| 00816765013182 | K111648 | 000 |
| 00816765013175 | K111648 | 000 |
| 00816765013168 | K111648 | 000 |
| 10816765013110 | K111648 | 000 |
| 10724995180383 | K111648 | 000 |