The following data is part of a premarket notification filed by Telemedic Systems Ltd with the FDA for Vitallink3 Mobile Vital Signs System.
| Device ID | K073094 |
| 510k Number | K073094 |
| Device Name: | VITALLINK3 MOBILE VITAL SIGNS SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | TELEMEDIC SYSTEMS LTD 10 BILLETFIELD Taunton, Somerset, GB Ta1 3nn |
| Contact | Gerald L Buss |
| Correspondent | Gerald L Buss TELEMEDIC SYSTEMS LTD 10 BILLETFIELD Taunton, Somerset, GB Ta1 3nn |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-01 |
| Decision Date | 2008-01-04 |
| Summary: | summary |