510(k) K844160
- Device
- VENTIBOX
- Applicant
- SYNCOR INTL. CORP.
- 510(k) number
- K844160
- Product code
- KPY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-12-17
- Date received
- 1984-10-24
- Regulation
- 892.6500
- Classification name
- Shield, Protective, Personnel
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELEANOR V CHIU
- Address
- 12847 Arroyo St. Sylmar CA US 91342 91342
FDA Registration Numbers#
- 2939388
- 3007594755
- 3003965134
- 3015416207
- 3009688745
- 3023863246
- 1225691
- 3003887292
- 3018781093
- 3015058854
- 3005599545
- 3003768277
- 3002806603
- 3015532203
- 3002532594
- 3003808764
- 3016763307
- 2024351
- 2431224
- 2518443
- 3025771437
- 3025001668
- 1061124
- 3043648115
- 1450835
- 1314417
- 3027976674
- 3014663932
- 2247992
- 9680861
- 3010583458
- 3009420946
- 3031755043
- 3005785003
- 3012841710
- 3003967959
- 3011526299
- 3039396083
- 3007369190
- 3038966231
- 3011529314
- 3011137372
- 3023152124
- 3033484057
- 3007165189
- 3007069733
- 3009540572
- 3034669683
- 3008808560
- 3020118
- 1037577
- 3008044484
- 3013443304
- 9710585
- 3011593607
- 1218386
- 3011310668
- 3008062466
- 3015219076
- 3010827261
- 3014700242
- 3045058049
- 3012690638
- 3031590635
- 3017180923
- 9611112
- 3027815
- 1820334
- 3016426851
- 3008931233
- 1225473
- 3008264111
- 3011659880
- 3016989300
- 8022247
- 3014342658
- 1219183
- 3013285519
- 1121142
- 3017636959
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KPY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110900 | DISPOSABLE THYROID COLLAR | Bloxr Corporation | 2011-06-24 |
| K962622 | INTRA-ORAL THERMOPLASTIC SHIELD | Medtec, Inc. | 1996-10-01 |
| K954456 | THERMOPLASTIC SHIELD | Medtec, Inc. | 1995-12-21 |
| K954146 | UTK-DTE AUTILARY SHIELD | Mallinckrodt Medical | 1995-12-06 |
| K953610 | AUKULYTE | Aukland Medical Plastics, Inc. | 1995-09-26 |
| K951004 | 2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4) | Kenex , Ltd. | 1995-04-10 |
| K951003 | KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5) | Kenex , Ltd. | 1995-04-03 |
| K940539 | STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM | Standard Imaging, Inc. | 1994-03-16 |
| K934206 | MAVIG ANGIO SHIELD MODELS 6290 & 6272 | F. Walter Hanel GmbH | 1993-10-07 |
| K912326 | DAVIS LEAD APRON - VARIOUS CATALOGUE NUMBERS | Davis Lead Aprons, Inc. | 1992-03-18 |
| K912327 | DAVIS LEAD APRON GONADAL SHIELD-VARIOUS CAT. NOS. | Davis Lead Aprons, Inc. | 1992-03-18 |
| K912378 | DAVIS LEAD APRON/RADIOGRAPHIC VARIOUS CAT. NUMBERS | Davis Lead Aprons, Inc. | 1992-03-18 |
| K900970 | RADIATION PROTECTION GLASSES | Infab Corp. | 1990-05-01 |
| K896511 | DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL | E.I. Dupont DE Nemours & Co., Inc. | 1989-12-22 |
| K896289 | RADIATION PROTECTION APRON | Infab Corp. | 1989-12-14 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases