The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbe’s Co2 Tubing/cap Sets.
| Device ID | K162152 |
| 510k Number | K162152 |
| Device Name: | Erbe’s CO2 Tubing/Cap Sets |
| Classification | Pump, Air, Non-manual, For Endoscope |
| Applicant | Erbe USA, Inc. 2225 Northwest Parkway Marietta, GA 30067 |
| Contact | John Tartal |
| Correspondent | John Tartal Erbe USA, Inc. 2225 Northwest Parkway Marietta, GA 30067 |
| Product Code | FEQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-02 |
| Decision Date | 2016-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147020696 | K162152 | 000 |
| 04065655000405 | K162152 | 000 |
| 04065655000863 | K162152 | 000 |
| 04065655000955 | K162152 | 000 |
| 04065655000986 | K162152 | 000 |
| 04065655001013 | K162152 | 000 |
| 04065655001044 | K162152 | 000 |
| 04065655001075 | K162152 | 000 |
| 04065655001105 | K162152 | 000 |
| 04050147022683 | K162152 | 000 |
| 04050147014503 | K162152 | 000 |
| 04050147014534 | K162152 | 000 |
| 04050147014558 | K162152 | 000 |
| 04050147020634 | K162152 | 000 |
| 04050147020641 | K162152 | 000 |
| 04065655000375 | K162152 | 000 |