510(k) K812676
- Device
- AMPLITONE-3
- Applicant
- PROGRESSIVE TECHNOLOGY, INC.
- 510(k) number
- K812676
- Product code
- LDE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-10-13
- Date received
- 1981-09-22
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3015220324
- 3003965134
- 3012421607
- 3031700059
- 3007703436
- 3013783488
- 3036497156
- 3045058049
- 3005652389
- 3026263452
- 3003882387
- 3006537699
- 3012777736
- 3014268334
- 3006157842
- 3010595915
- 3016904853
- 3025413691
- 3030626857
- 3012896103
- 3044150131
- 8010427
- 3011137372
- 3004527595
- 3015997711
- 2081040
- 3007699082
- 2434008
- 3015058854
- 3011983031
- 3016764932
- 3031582434
- 9610621
- 9611112
- 3014579161
- 3008264111
- 3002808270
- 3038988287
- 9610816
- 1250045
- 3031564283
- 3001620590
- 3016452327
- 3034669683
- 3013298431
- 3015895045
- 2027062
- 3027187888
- 2245574
- 2434982
- 3004488394
- 3038772401
- 3007740533
- 1417592
- 3017303999
- 3006056044
- 1054713
- 2427500
- 2435946
- 3014610488
- 1720747
- 9710103
- 8022077
- 3021244221
- 3004485927
- 3015422337
- 9680874
- 3006979678
- 3003622639
- 9611283
- 3011570437
- 3013530901
- 3013557562
- 3033536319
- 9613910
- 3003782614
- 3015745029
- 3036779619
- 8040278
- 1832894
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 |
| 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 |
Legacy Summary#
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FDA Review#
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