510(k) K110628
- Device
- SIMPLEABI
- Applicant
- NEWMAN MEDICAL
- 510(k) number
- K110628
- Product code
- JAF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-05-12
- Date received
- 2011-03-03
- Regulation
- 892.1540
- Classification name
- Monitor, Ultrasonic, Nonfetal
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- SPENCER NEWMAN
- Address
- 5350 Vivian St. Unit C Arvada CO US 80002 80002
FDA Registration Numbers#
- 1216677
- 3006265099
- 1222117
- 3010611950
- 1937397
- 3007708502
- 2183319
- 9611033
- 3030151584
- 3006680097
- 1000589001
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JAF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242487 | Laminar P1 (LDH-HW-001) | Laminar Digital Health, Inc. | 2024-12-13 |
| K141657 | THD REVOLUTION | Thd Spa | 2015-02-24 |
| K093393 | LIFEDOP MODEL 300ABI | Summit Doppler Systems, Inc. | 2009-12-24 |
| K090009 | THD SLIDE ONE | Thd Spa | 2009-01-28 |
| K081429 | THD SLIDE | Thd Spa | 2008-07-30 |
| K070815 | THD | G.F. S.R.L. | 2007-06-20 |
| K063600 | VISTA AVS | Summit Doppler Systems, Inc. | 2006-12-19 |
| K060064 | STETHOFLUX | Odvi | 2006-04-10 |
| K052067 | DOPPLER GUIDED PROCTOSCOPE, MODEL 500H | Multigon Industries, Inc. | 2005-08-29 |
| K010521 | NICOLET VERSALAB | Nicolet Biomedical | 2001-03-09 |
| K982635 | CAREDOP II | Nicolet Biomedical | 1998-08-07 |
| K973336 | IMEX STETHODOP | Imex Medical Systems, Inc. | 1998-02-05 |
| K973857 | FLOSTAT VASCULAR REPORT GENERATOR (VRG) | Biomedix, Inc. | 1997-12-29 |
| K973644 | FLOSTAT VASCULAR LAB | Biomedix, Inc. | 1997-12-23 |
| K943338 | BIOSENSOR BIDOP VASCULAR TEST SYSTEM | Biosensor Corp. | 1996-04-12 |
Legacy Summary#
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FDA Review#
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