510(k) K123821
- Device
- AIO HD OTOSCOPE
- Applicant
- BLUE FOCUS
- 510(k) number
- K123821
- Product code
- ERA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-05-17
- Date received
- 2012-12-12
- 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
- KI CHEOL HAN
- Address
- 965 Oakland Rd. Suite 2b Lawrenceville GA US 30044 30044
FDA Registration Numbers#
- 3009685433
- 3009590187
- 3010453122
- 1222997
- 8044015
- 9611112
- 3015544237
- 3007123908
- 3030447506
- 3004605493
- 3030626857
- 3015316279
- 2431166
- 3018507299
- 9610617
- 3016854720
- 3027645317
- 2427500
- 3009703496
- 3021316061
- 1222616
- 3005034064
- 3004892425
- 8040278
- 8010573
- 3002090132
- 8021788
- 3010041511
- 3010181894
- 3005536872
- 1054713
- 2434982
- 3014615697
- 3008338766
- 8010427
- 8040263
- 3004644065
- 9611283
- 3009155880
- 9515015
- 3004598675
- 3008699634
- 3017026146
- 8010418
- 3010399422
- 3011585752
- 3003759558
- 3012541976
- 3003244954
- 3010707607
- 3015895045
- 3009255580
- 3009118476
- 3013273457
- 1317202
- 3030410270
- 3014233600
- 3008808049
- 3014339847
- 3005273623
- 9613910
- 3011611571
- 3005527904
- 9615001
- 3013831261
- 3039411298
- 3034603279
- 1000391004
- 3003622639
- 3002761766
- 3032874372
- 3004168759
- 8010704
- 3010774780
- 3018783553
- 3013358456
- 1316463
- 3004001706
- 3017177487
Source Documents#
Other 510(k) Records For Product Code ERA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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