The following data is part of a premarket notification filed by Aalto Scientific Ltd. with the FDA for Aalto Scientific Liquid Cardiac Control.
| Device ID | K954074 |
| 510k Number | K954074 |
| Device Name: | AALTO SCIENTIFIC LIQUID CARDIAC CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | AALTO SCIENTIFIC LTD. 1160 JOSHUA WAY Vista, CA 92083 -7836 |
| Contact | Kevin Jones |
| Correspondent | Kevin Jones AALTO SCIENTIFIC LTD. 1160 JOSHUA WAY Vista, CA 92083 -7836 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-30 |
| Decision Date | 1995-10-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727010971 | K954074 | 000 |
| 00817274021286 | K954074 | 000 |
| 00817274021279 | K954074 | 000 |