The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for 9055 Irca Option For System Athena 9050 Nt.
| Device ID | K930134 |
| 510k Number | K930134 |
| Device Name: | 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT |
| Classification | Electrocardiograph |
| Applicant | S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Contact | Morten Nielsen |
| Correspondent | Morten Nielsen S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-12 |
| Decision Date | 1993-04-09 |