510(k) K871369
- Device
- VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES:
- Applicant
- KEELER INSTRUMENTS, INC.
- 510(k) number
- K871369
- Product code
- LDE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-09-24
- Date received
- 1987-04-07
- 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
- VAN ARSDALE
- Address
- 456 Pkwy. Broomall PA US 19008 19008
FDA Registration Numbers#
- 3009685433
- 3016489998
- 3007123908
- 9611112
- 3034669683
- 3026263452
- 3031192529
- 3030626857
- 1250045
- 2431166
- 1422443
- 3011587065
- 3034605486
- 2427500
- 3010595915
- 3027135885
- 3016452327
- 3000126629
- 8040278
- 8021788
- 3005536872
- 3016170451
- 1054713
- 2434982
- 8010427
- 9611283
- 3036497156
- 3015173212
- 1314417
- 3004111573
- 3004519921
- 3031582434
- 3025413691
- 3012541976
- 2245574
- 3006157842
- 3004111085
- 8043816
- 3015895045
- 3008496560
- 3042481106
- 9680874
- 3011280379
- 3005273623
- 3009560891
- 3002808270
- 3011611571
- 3015422337
- 9613910
- 3001620590
- 3003622639
- 8043685
- 3011570437
- 3003965134
- 3006537699
- 1316463
- 3030220356
- 8022890
- 3011191255
- 3020188747
- 3035708926
- 1420054
- 9680548
- 3005652389
- 3009154535
- 1018470
- 3021244221
- 3038988287
- 3012421607
- 3012104670
- 3015058854
- 3009745997
- 3006979678
- 2027062
- 3005327291
- 3026875454
- 3003418325
- 3024088964
- 3031564283
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 |
| K895545 | V*S*R(TM) SCOPE | Vsr Enterprises Corp. | 1989-11-15 |
| K890126 | KAMED STETHOSCOPE | D.R.G. | 1989-04-21 |
| K882324 | STETH-SHIELD ACCESSORY TO A STETHOSCOPE | Steth-Shield, Inc. | 1988-07-18 |
| 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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