The following data is part of a premarket notification filed by Electromed Intl., Ltd. with the FDA for View Archiving Station.
| Device ID | K971176 |
| 510k Number | K971176 |
| Device Name: | VIEW ARCHIVING STATION |
| Classification | System, X-ray, Angiographic |
| Applicant | ELECTROMED INTL., LTD. 310,BOULE.INDUSTRIEL ST.-EUSTACHE Quebec, CA J7r 5v3 |
| Contact | James Reidl |
| Correspondent | James Reidl ELECTROMED INTL., LTD. 310,BOULE.INDUSTRIEL ST.-EUSTACHE Quebec, CA J7r 5v3 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-31 |
| Decision Date | 1997-09-03 |
| Summary: | summary |