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#
- 3007740533
- 3013557562
- 3004527595
- 3004111085
- 3013783488
- 3014982318
- 1832894
- 3038988287
- 3015895045
- 3015745029
- 3015220324
- 3006389770
- 9680900
- 3013784566
- 2427500
- 3003782614
- 3003674698
- 3009560891
- 3005273623
- 3002808270
- 3013298431
- 9680548
- 3031564283
- 9681758
- 3009685433
- 3007699082
- 3005536872
- 1000379039
- 2081040
- 3005652389
- 9680874
- 1250045
- 3011280379
- 3034669683
- 1422443
- 3033536319
- 3042481106
- 9610612
- 3043533459
- 3010395155
- 3006056044
- 1417592
- 3012541976
- 3011371465
- 3004784770
- 2434982
- 3014610488
- 3004488394
- 3031192529
- 3008264111
- 2434008
- 1018470
- 8010482
- 3003418325
- 1054713
- 3005327291
- 3016763307
- 3034605486
- 8010427
- 3038772401
- 3030220356
- 3013322724
- 8040278
- 2435946
- 3030626857
- 3012777736
- 1422634
- 3004519921
- 9611112
- 3011489684
- 3026263452
- 2183650
- 3036497156
- 3006056037
- 8010298
- 3023809973
- 3027187888
- 3012494290
- 9614093
- 2431166
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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