510(k) K854082
- Device
- Porta-pole Tm Medical Equipment Pole W/fold
- Applicant
- GRAY WAVE CORP.
- 510(k) number
- K854082
- Product code
- FOX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-11-01
- Date received
- 1985-10-07
- Regulation
- 880.6990
- Classification name
- Stand, Infusion
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MYRON NORENBERT
- Address
- 27272 Cool Water Ranch Rd. Valley Center CA US 92082 92082
FDA Registration Numbers#
- 3005024024
- 3003749961
- 3007662999
- 8043933
- 9681860
- 1423507
- 3010605276
- 8022787
- 1824206
- 3002808466
- 3004194020
- 3013685983
- 9681599
- 3007417753
- 3003123807
- 3016734231
- 3036470679
- 1221934
- 3011659880
- 1423662
- 1319639
- 3019505063
- 3031562615
- 3011468686
- 3004957206
- 3010885402
- 3038141559
- 3003781173
- 3009273990
- 2182762
- 1928237
- 3015967359
- 3012798826
- 9611451
- 1921846
- 3008719017
- 3008808123
- 2523676
- 3023272766
- 9680168
- 3007734888
- 3032916632
- 3005214422
- 8020785
- 3005380088
- 1423537
- 3011526299
- 3006897996
- 3007203968
- 3038623066
- 3012316249
- 3012579728
- 3033814356
- 3009591865
- 3007305485
- 9615896
- 3020188747
- 3011816755
- 3007886583
- 3008363441
- 3004024088
- 3011063460
- 3031582440
- 3038632739
- 3006697241
- 3018094310
- 3006342679
- 3011537487
- 3015612252
- 3006786907
- 2518157
- 9615393
- 3019315696
- 8030607
- 3012345110
- 2024022
- 8043685
- 3006897028
- 3011506263
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 |
| K946201 | STAND, INFUSION | Medical Specialties, Inc. | 1995-04-18 |
| 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 |