The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Edslab Closed Injectate Delivery System.
| Device ID | K811399 |
| 510k Number | K811399 |
| Device Name: | EDSLAB CLOSED INJECTATE DELIVERY SYSTEM |
| Classification | Probe, Thermodilution |
| Applicant | AMERICAN EDWARDS LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KRB |
| CFR Regulation Number | 870.1915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-19 |
| Decision Date | 1981-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103497143 | K811399 | 000 |
| 07460691949973 | K811399 | 000 |
| 07460691949997 | K811399 | 000 |
| 07460691950009 | K811399 | 000 |
| 07460691950016 | K811399 | 000 |
| 07460691950023 | K811399 | 000 |
| 07460691955448 | K811399 | 000 |
| 00690103003260 | K811399 | 000 |
| 00690103197150 | K811399 | 000 |
| 00690103197167 | K811399 | 000 |
| 00690103197143 | K811399 | 000 |