510(k) K895545
- Device
- V*S*R(TM) SCOPE
- Applicant
- VSR ENTERPRISES CORP.
- 510(k) number
- K895545
- Product code
- LDE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-11-15
- Date received
- 1989-09-13
- Regulation
- 870.1875
- Classification name
- Stethoscope, Manual
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- EGGERS, JR.
- Address
- P.O. Box 819 Walton Beach FL US 32549 32549
FDA Registration Numbers#
- 1221765
- 3009560891
- 3011489684
- 3012680643
- 3026875454
- 3030626857
- 8043965
- 3034669683
- 3003882387
- 3011371465
- 3005536872
- 3006979678
- 3016170451
- 8010482
- 3031841433
- 3008936260
- 3025413691
- 3011611571
- 3013783488
- 3018269548
- 3004784770
- 9611112
- 3016904853
- 3009745997
- 3009155756
- 3036779619
- 3015745029
- 3014421917
- 1420054
- 3011065399
- 3007740533
- 9613910
- 1422443
- 3014982318
- 9680411
- 3006056044
- 3005616800
- 9610612
- 3015069921
- 3014579161
- 3008264111
- 8010298
- 2245574
- 3035708926
- 3016452327
- 3031564283
- 2434008
- 3001620590
- 1250045
- 3038772401
- 3011587065
- 3011137372
- 8022890
- 3044150131
- 3038624873
- 3017805218
- 3012777736
- 3000126629
- 3007123908
- 3011191255
- 9614093
- 3041276591
- 2427500
- 3042272797
- 9680548
- 9681758
- 3006389770
- 2431166
- 3004527595
- 3014268334
- 3003965134
- 3013322724
- 3015422337
- 8043816
- 3003897648
- 3023339256
- 3004111573
- 3006210673
- 3006513362
- 3011280379
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LDE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K945082 | CYPRESS MEDICAL PRODUCTS STETHOSCOPE | Cypress Medical Products, Ltd. | 1994-12-08 |
| K944337 | VARIOUS STETHOSCOPES | Rud Riester GmbH & CO KG | 1994-11-30 |
| K940578 | MANUAL STETOSCOPE | Bhs Intl., Inc. | 1994-04-26 |
| K935944 | PROSCOPES AND ADSCOPES | American Diagnostic Corp. | 1994-03-03 |
| K923327 | STETHOSCOPE COVER | Anup Chakraborty Co. | 1992-11-03 |
| K924095 | TIMEOSCOPE AND FLEXISCOPE | Stethoscopes of America, Inc. | 1992-10-20 |
| K914100 | STETHOSCOPE | Atlas Medical Products, Inc. | 1991-11-07 |
| K912128 | MAXI-SCOPE OR ULTRA-SCOPE | Seiichi Mfg., Inc. | 1991-06-28 |
| K905487 | VARIOUS TYPES OF STETHOSCOPES | Liaoning-Usa Corp. | 1991-04-09 |
| K904547 | STETHOSCOPE | Kimball Industries Co., Ltd. | 1991-03-21 |
| K890126 | KAMED STETHOSCOPE | D.R.G. | 1989-04-21 |
| K882324 | STETH-SHIELD ACCESSORY TO A STETHOSCOPE | Steth-Shield, Inc. | 1988-07-18 |
| K871369 | VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES: | Keeler Instruments, Inc. | 1987-09-24 |
| K860473 | DIFFERENTIAL STETHOSCOPE W/DUAL HEADS; STEREOSCOPE | Schering Corp. | 1986-08-14 |
| K854771 | SALTZMAN STETHOSCOPE HEAD | K & S Medicorp | 1986-05-09 |
Legacy Summary#
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FDA Review#
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