The following data is part of a premarket notification filed by Machida America, Inc. with the FDA for Machida America Model Ac-5000 Automatic Disinfect..
| Device ID | K871712 |
| 510k Number | K871712 |
| Device Name: | MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. |
| Classification | Washer, Cleaner, Automated, Endoscope |
| Applicant | MACHIDA AMERICA, INC. 40 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Ron Pell |
| Correspondent | Ron Pell MACHIDA AMERICA, INC. 40 RAMLAND RD. Orangeburg, NY 10962 |
| Product Code | NVE |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-04 |
| Decision Date | 1988-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333242788 | K871712 | 000 |
| 00677964064333 | K871712 | 000 |
| 00677964064340 | K871712 | 000 |
| 00677964064357 | K871712 | 000 |
| 00677964064364 | K871712 | 000 |
| 00677964064371 | K871712 | 000 |
| 00677964085222 | K871712 | 000 |
| 00677964085246 | K871712 | 000 |
| 00677964085253 | K871712 | 000 |
| 00677964064326 | K871712 | 000 |
| 00677964064302 | K871712 | 000 |
| 00677964089039 | K871712 | 000 |
| 00677964089091 | K871712 | 000 |
| 00677964089046 | K871712 | 000 |
| 00677964033070 | K871712 | 000 |
| 00677964064210 | K871712 | 000 |
| 00677964064227 | K871712 | 000 |
| 00677964064258 | K871712 | 000 |
| 00677964064296 | K871712 | 000 |
| 00677964085260 | K871712 | 000 |
| 00677964085277 | K871712 | 000 |
| 00677964089060 | K871712 | 000 |
| 00677964021695 | K871712 | 000 |
| 00677964021725 | K871712 | 000 |
| 00677964052484 | K871712 | 000 |
| 00677964052491 | K871712 | 000 |
| 04961333242757 | K871712 | 000 |
| 04961333242764 | K871712 | 000 |
| 04961333242771 | K871712 | 000 |
| 00677964089022 | K871712 | 000 |
| 00677964089015 | K871712 | 000 |
| 00677964085284 | K871712 | 000 |
| 00677964085291 | K871712 | 000 |
| 00677964088957 | K871712 | 000 |
| 00677964088964 | K871712 | 000 |
| 00677964088971 | K871712 | 000 |
| 00677964088988 | K871712 | 000 |
| 00677964088995 | K871712 | 000 |
| 00677964089008 | K871712 | 000 |
| 00677964072970 | K871712 | 000 |