510(k) K950983
- Device
- Imedge Digita Otoscope Or Digital Video Otoscope
- Applicant
- INTROSPECT, INC.
- 510(k) number
- K950983
- Product code
- ERA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-04-12
- Date received
- 1995-03-03
- Regulation
- 874.4770
- Classification name
- Otoscope
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD C HAWLEY
- Address
- 5641 Zumbra Dr. Excelsior MN US 55331 55331
FDA Registration Numbers#
- 1222616
- 3013596041
- 3013901429
- 9614093
- 3006113277
- 3022946813
- 3009590187
- 9614069
- 3015220324
- 9610612
- 3015316279
- 3003782614
- 3014903258
- 2243757
- 3015398570
- 3016170496
- 3008494403
- 8010704
- 3015512299
- 3011310592
- 3005536872
- 3006897996
- 2431166
- 3033536319
- 3043088937
- 9612197
- 3005527904
- 1000379039
- 3007123908
- 3009255580
- 3016248634
- 3027303024
- 3014339847
- 9613910
- 3010202439
- 3003610251
- 3000682787
- 3015895045
- 8010573
- 3021680161
- 3007751820
- 3001644167
- 3007703436
- 3004052117
- 3013273457
- 3009703496
- 3009424883
- 3012896103
- 3004001706
- 8010273
- 3003759558
- 3007532396
- 8010427
- 3027645317
- 3013188547
- 8021788
- 3011371465
- 3017805218
- 8043235
- 3035371880
- 3018783553
- 2183416
- 3009745997
- 9611112
- 3042888274
- 9614434
- 3014908171
- 3026875454
- 3015552886
- 1221826
- 3042158672
- 8044015
- 3007739031
- 3005739529
- 3009010438
- 3010774780
- 3010419931
- 1720747
- 3035708926
Source Documents#
Other 510(k) Records For Product Code ERA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123821 | AIO HD OTOSCOPE | Blue Focus | 2013-05-17 |
| K121326 | LANTOS 3D EAR SCANNER | Lantos Technologies | 2013-01-25 |
| K110326 | OSRAM ITOS | Osram Sylvania, Inc. | 2011-10-27 |
| K945264 | OPTUS OTOSCOPES | Optus, Inc. | 1996-02-02 |
| K955043 | WELCH ALLYN BI-OTOSCOPE | Welch Allyn, Inc. | 1995-11-14 |
| K952578 | WELCH ALLY OTOSCOPE | Welch Allyn, Inc. | 1995-07-10 |
| K950913 | PERFECT, ENT SET, PRAKTIKANT, DE LUXE | Rudolf Riester GmbH & Co. KG | 1995-05-12 |
| K950788 | OTOSCOPE A-34 | Neitz Instruments Company, Ltd. | 1995-05-03 |
| K951050 | SPECULUM, ENT (S3) | Pedia Pals, Inc. | 1995-04-17 |
| K951049 | SPECULUM, ENT (S3) | Pedia Pals, Inc. | 1995-04-17 |
| K951255 | IMEDGE VIDEO OSTOSCOPE (ANALOG) | Introspect, Inc. | 1995-04-13 |
| K950787 | WELCH ALLYN OTOSCOPE | Welch Allyn, Inc. | 1995-04-06 |
| K946043 | H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG | Rudolf Riester GmbH & Co. KG | 1995-03-08 |
| K943721 | OTOVIEW TELESCOPIC OTOSCOPES | Smith & Nephew, Inc. | 1994-11-18 |
| K944897 | HOME CARE EAR EXAMINATIO KIT | Home Care Instruments, Inc. | 1994-11-08 |