The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Type 9541 Recorder, Paper Chart.
| Device ID | K895111 |
| 510k Number | K895111 |
| Device Name: | TYPE 9541 RECORDER, PAPER CHART |
| Classification | Recorder, Paper Chart |
| Applicant | S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Contact | Lisbeth Isbrandt |
| Correspondent | Lisbeth Isbrandt S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Product Code | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-03 |
| Decision Date | 1990-01-26 |