The following data is part of a premarket notification filed by Telemedic Systems, Inc. with the FDA for Vitallink 1200 Mobile Vital Signs Systems (vl 1200 System).
| Device ID | K010732 |
| 510k Number | K010732 |
| Device Name: | VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM) |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | TELEMEDIC SYSTEMS, INC. P.O. BOX 3515 Redmond, WA 98073 -3515 |
| Contact | Stenen Chernoff |
| Correspondent | Stenen Chernoff TELEMEDIC SYSTEMS, INC. P.O. BOX 3515 Redmond, WA 98073 -3515 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-12 |
| Decision Date | 2001-09-27 |