510(k) K950913
- Device
- PERFECT, ENT SET, PRAKTIKANT, DE LUXE
- Applicant
- RUDOLF RIESTER GMBH & CO. KG
- 510(k) number
- K950913
- Product code
- ERA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-05-12
- Date received
- 1995-02-23
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KARLHEINZ RIESTER
- Address
- Postfach 35 Bruckstrabe 31 D-72417 Jungingen DE
FDA Registration Numbers#
- 3030839824
- 3026875454
- 1528142
- 3021680161
- 3004168759
- 3030626857
- 9515015
- 3005739529
- 3011182134
- 3003882387
- 3011371465
- 3006087789
- 9614434
- 3039411298
- 3014233600
- 3005536872
- 3030535035
- 8010482
- 3020777598
- 3009010438
- 3043088937
- 3011310592
- 3015512299
- 3011611571
- 3015286905
- 3011209790
- 3017026146
- 3014342096
- 3039414397
- 3001644167
- 9710609
- 3014903258
- 3004784770
- 3015544237
- 3021666757
- 3009745997
- 9611112
- 3004644065
- 3004605493
- 3009420946
- 3015246392
- 3002834291
- 3006546082
- 3009118476
- 3015398570
- 9613910
- 3017644066
- 3030410270
- 3009424883
- 3042888274
- 3018507299
- 3017177487
- 9610612
- 3008386587
- 9710051
- 9612197
- 3014579161
- 3003431869
- 3043139378
- 8010298
- 3006891796
- 9611062
- 9680002
- 3015146106
- 8030607
- 3004052117
- 3035708926
- 2434008
- 9613073
- 3011689956
- 8044015
- 3008808049
- 3027037494
- 3013831261
- 3004598675
- 1421307
- 3011137372
- 8022890
- 3016678045
- 3010419931
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ERA #
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|---|---|---|---|
| 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 |
| 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 |
| 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 |