510(k) K951255
- Device
- Imedge Video Ostoscope (analog)
- Applicant
- INTROSPECT, INC.
- 510(k) number
- K951255
- Product code
- ERA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-04-13
- 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#
- 9710051
- 1222616
- 3004784770
- 3004168759
- 3014903258
- 8010298
- 9611283
- 3002761766
- 3034731361
- 3011689956
- 3011585752
- 3011499367
- 3013298431
- 3018783553
- 3003418325
- 3012541976
- 3008808049
- 3004765453
- 3020994856
- 3013358456
- 3004644065
- 3015246392
- 3002858762
- 3013517171
- 1058264
- 9614062
- 2431166
- 3004598675
- 8010704
- 3015398570
- 3014342096
- 3009745997
- 3010353847
- 3039414397
- 8010427
- 3005581270
- 3015895045
- 3009703496
- 3013596041
- 3015316279
- 2434008
- 3021666757
- 3027645317
- 3043138885
- 3006188092
- 3006546082
- 2427500
- 3012678246
- 3021680161
- 3007123908
- 9680002
- 3000279801
- 8010273
- 9515015
- 3003622639
- 3010774780
- 3002834291
- 3038624873
- 3004485927
- 3042158672
- 3015286905
- 3016854720
- 3006252153
- 3017026146
- 3006113277
- 3016170496
- 3000682787
- 2085947
- 3010707607
- 3001584149
- 8044015
- 3016248634
- 3009685433
- 8010482
- 9612278
- 3005034064
- 3014337591
- 2214133
- 3001644167
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 |
| K951049 | SPECULUM, ENT (S3) | Pedia Pals, Inc. | 1995-04-17 |
| K951050 | SPECULUM, ENT (S3) | Pedia Pals, Inc. | 1995-04-17 |
| K950983 | IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE | Introspect, Inc. | 1995-04-12 |
| 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 |