The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Mechanical Inflation Device.
| Device ID | K862547 |
| 510k Number | K862547 |
| Device Name: | MECHANICAL INFLATION DEVICE |
| Classification | Injector And Syringe, Angiographic |
| Applicant | AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Contact | Cole, Ph.d. |
| Correspondent | Cole, Ph.d. AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-03 |
| Decision Date | 1986-09-03 |