The following data is part of a premarket notification filed by Athena Gtx with the FDA for Wvsm (wireless Vital Signs Monitor), Model 5.0.
| Device ID | K101674 |
| 510k Number | K101674 |
| Device Name: | WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | ATHENA GTX 3620 SW61ST STREET SUITE 395 Des Moines, IA 50321 |
| Contact | Sean Mahoney |
| Correspondent | Sean Mahoney ATHENA GTX 3620 SW61ST STREET SUITE 395 Des Moines, IA 50321 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-15 |
| Decision Date | 2010-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3945700025050 | K101674 | 000 |
| B3945000025040 | K101674 | 000 |
| B3945000025030 | K101674 | 000 |
| B3945000025020 | K101674 | 000 |
| B3945000025010 | K101674 | 000 |
| B3945000001120 | K101674 | 000 |
| B3945000001010 | K101674 | 000 |
| B3944670006010 | K101674 | 000 |
| B3944060005010 | K101674 | 000 |
| B3943900004000 | K101674 | 000 |
| B3945300025010 | K101674 | 000 |
| B3944670036010 | K101674 | 000 |
| B3944670019020 | K101674 | 000 |
| B3945000025050 | K101674 | 000 |
| B3945000025060 | K101674 | 000 |
| B3945100004010 | K101674 | 000 |
| B3945700025040 | K101674 | 000 |
| B3945700025030 | K101674 | 000 |
| B3945700025020 | K101674 | 000 |
| B3945700025010 | K101674 | 000 |
| B3945700024010 | K101674 | 000 |
| B3945700004020 | K101674 | 000 |
| B3945700004010 | K101674 | 000 |
| B3945500039010 | K101674 | 000 |
| B3945300002010 | K101674 | 000 |
| B3945100004040 | K101674 | 000 |
| B3945100004030 | K101674 | 000 |
| B3945100004020 | K101674 | 000 |
| B3944670063010 | K101674 | 000 |