510(k) K946201
- Device
- STAND, INFUSION
- Applicant
- MEDICAL SPECIALTIES, INC.
- 510(k) number
- K946201
- Product code
- FOX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-04-18
- Date received
- 1994-12-21
- Regulation
- 880.6990
- Classification name
- Stand, Infusion
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN WHISNANT
- Address
- 58 Norfolk Ave. South Easton MA US 02375 02375
FDA Registration Numbers#
- 3043479340
- 1423507
- 3026818268
- 3009247326
- 1221934
- 8021995
- 3015465361
- 3011237770
- 3003152976
- 3014555455
- 1450997
- 3009282549
- 3010047033
- 1518293
- 3023189540
- 9614609
- 3015526491
- 3031082325
- 3006897028
- 1928237
- 3001452523
- 8043933
- 3008114965
- 3012798826
- 3007029061
- 3025369303
- 2921578
- 8020347
- 1526863
- 3010303097
- 2521402
- 3015286905
- 3015439135
- 3001644167
- 2529571
- 3009273990
- 3010987649
- 3008363441
- 3012579728
- 3013875526
- 1722070
- 3043749706
- 3011475060
- 1423537
- 3032916632
- 3014421917
- 3021073836
- 3009028104
- 3008351005
- 9618009
- 3030681105
- 3011816755
- 9613910
- 3014982318
- 3008879776
- 3044563261
- 3001675293
- 3013524663
- 1825014
- 3005380088
- 3011390406
- 3018094310
- 2182762
- 3004491689
- 3003749961
- 3007305485
- 3004957206
- 3012268721
- 3014293077
- 1526605
- 3001040506
- 3012316249
- 8030607
- 2024168
- 3043236281
- 3027486074
- 3009327812
- 3037012186
- 3038191348
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FOX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K980336 | IV STANDS | Clinton Industries, Inc. | 1998-04-06 |
| K964782 | MEDRAD CONTRAST HOLDER | Medrad, Inc. | 1997-02-25 |
| K961470 | PORT-A-POLE | Prins Medical Ind., Inc. | 1996-07-22 |
| K960027 | HIGH VOLUME I.V. & IRRIGATION TOWER | Allen Medical Systems, Inc. | 1996-03-12 |
| K952196 | IV POLE/STAND | Valentine Intl. , Ltd. | 1995-07-31 |
| K950367 | IV SHUTTLE | Equipment Concepts, Inc. | 1995-04-26 |
| K944580 | FLEXSYS MOBILEMATE EQUIPMENT STAND | Hill-Rom, Inc. | 1995-03-17 |
| K932498 | MOBILE CARE IV STAND | Mobile Care, Inc. | 1993-10-27 |
| K925066 | PNEUMATIC IRRIGATION STANDARD | Arthrodyn, Inc. | 1993-07-28 |
| K912010 | I.V. SKY-HOOK | Dina - Industria, Comercio E Exportacao , Ltd. | 1991-08-19 |
| K900981 | INTRAVENOUS STAND OR IV STAND | Travl-Med Infusion Device Transport System | 1990-03-27 |
| K895776 | AIV SYSTEMS' IV POLES | Automated IV Systems, Inc. | 1990-02-28 |
| K893597 | HYDRAULIC IV POLE | Arthro-Medic, Inc. | 1989-10-10 |
| K883133 | HANGER, INTRAVENOUS/I.V. BAG HANGER OR HOLDER | Ferguson Medical | 1988-11-21 |
| K883260 | DITTMAR POWER LIFTER | Dittmar and Penn Corp. | 1988-11-07 |
Legacy Summary#
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FDA Review#
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