The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Erbeflo Clevercap Hybrid Tubing/cap Set For Pentax Scopes, Erbeflo Clevercap Hybrid Co2 Tubing/cap Set For Olympus 160/1.
| Device ID | K132340 |
| 510k Number | K132340 |
| Device Name: | ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 |
| Classification | Pump, Air, Non-manual, For Endoscope |
| Applicant | ERBE USA, INC. 2225 NORTHWEST PKWY. Marietta, GA 30067 |
| Contact | John Tartal |
| Product Code | FEQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-07-26 |
| Decision Date | 2013-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04050147013766 | K132340 | 000 |
| 04065655000894 | K132340 | 000 |
| 04065655000924 | K132340 | 000 |
| 04050147013216 | K132340 | 000 |
| 04050147012820 | K132340 | 000 |
| 04050147012837 | K132340 | 000 |
| 04050147013278 | K132340 | 000 |
| 04050147013414 | K132340 | 000 |
| 04050147013506 | K132340 | 000 |
| 04050147013520 | K132340 | 000 |
| 04050147013537 | K132340 | 000 |
| 04050147013605 | K132340 | 000 |
| 04050147021105 | K132340 | 000 |
| 04050147013025 | K132340 | 000 |
| 04050147013728 | K132340 | 000 |
| 04050147013742 | K132340 | 000 |
| 04065655000825 | K132340 | 000 |