VASCULAB #VSC21
FDA 510(k) clearance K812609 · decided 1981-10-02
Clearance details
- K-number
- K812609
- Device name
- VASCULAB #VSC21
- Applicant
- Medasonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-09-15
- Decision date
- 1981-10-02
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- JOM
- Device class
- 2
- Regulation number
- 870.2780
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| PADnet Xpress (K220527) | Collaborative Care Diagnostics, LLC, D.B.A. Biomedix | 2022-10-20 |
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| VitalScan ANS (K191266) | Medeia, Inc. | 2020-01-15 |
| Automated ankle brachial pressure index measuring device (K172655) | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | 2018-01-11 |
| TBL-ABI System (K173696) | Ld Technology, LLC | 2017-12-19 |
| TM-ABI system (K143152) | Ld Technology, LLC | 2015-07-22 |
| QuantaFlo (K143094) | Semler Scientific, Inc. | 2015-03-05 |
| BODYTRONIC 200 (K123921) | Bauerfeind AG | 2013-04-26 |
| DOPPLEX ABILITY (K121108) | Huntleigh Healthcare | 2013-01-03 |
| PADNET 2.0 (K122281) | Biomedix, Inc. | 2012-08-29 |
Recalls involving this device
No recalls on record reference this clearance.