510(k) K964782
- Device
- MEDRAD CONTRAST HOLDER
- Applicant
- MEDRAD, INC.
- 510(k) number
- K964782
- Product code
- FOX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-02-25
- Date received
- 1996-11-27
- Regulation
- 880.6990
- Classification name
- Stand, Infusion
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SANDRA A PAVLOVIC
- Address
- One Medrad Dr. Indianola PA US 15051 15051
FDA Registration Numbers#
- 3003587684
- 8022752
- 1221934
- 3010675897
- 1045254
- 2027804
- 3003781173
- 3008808123
- 3006342679
- 3010605276
- 3029929134
- 8043933
- 3007886583
- 3015414875
- 3032916632
- 3010373263
- 9614609
- 2134265
- 3007734888
- 2182762
- 3010595915
- 3027486074
- 3023189540
- 1831750
- 3010394125
- 3012706378
- 3033506545
- 3025369303
- 3016734231
- 3005285078
- 2024168
- 3010817335
- 3010987649
- 3013495708
- 1825014
- 9617277
- 2936485
- 3009683397
- 3017607477
- 9680933
- 3015058854
- 3007305485
- 3008881803
- 3034729907
- 3038623066
- 9616567
- 3004024088
- 3005024024
- 3014293077
- 3008114965
- 3019505063
- 3013875526
- 3007029061
- 3009247326
- 2023337
- 3006061749
- 3012316249
- 3006721341
- 9617566
- 3003775119
- 3027847726
- 3001644167
- 3013298431
- 3032171543
- 3011011193
- 3012798826
- 3012268721
- 1416980
- 9618009
- 1518293
- 3014555455
- 1417592
- 3007417753
- 3013875599
- 3015286905
- 3033814356
- 3008386649
- 3042262500
- 9615896
Source Documents#
Other 510(k) Records For Product Code FOX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K980336 | IV STANDS | Clinton Industries, Inc. | 1998-04-06 |
| 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 |
| K884341 | CRITICAL CARE I.V. STAND STABILIZING BRACKET | Rbd Medical, Inc. | 1988-11-07 |
Legacy Summary#
summary
FDA Review#
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