510(k) K234096
- Device
- MonoStereo
- Applicant
- Medicaltek Co., Ltd.
- 510(k) number
- K234096
- Product code
- EOB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-19
- Date received
- 2023-12-26
- Regulation
- 874.4760
- Classification name
- Nasopharyngoscope (Flexible Or Rigid)
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Shen Ching (James) Yeh
- Address
- 4f., #26 Keya Rd. Daya Dist. Taichung City TW 428 428
FDA Registration Numbers
- 3024021261
- 1526611
- 3015316279
- 2243757
- 3014605202
- 2244478
- 3008494403
- 3014334038
- 1057421
- 3005423519
- 8044091
- 3044675089
- 1833700
- 3006345872
- 3005809810
- 3005527904
- 3011416394
- 3010264076
- 3033509898
- 8010047
- 8044098
- 3011050570
- 1052728
- 3010202439
- 2936485
- 3018094310
- 1218141
- 1421101
- 8010573
- 1048735
- 3009171251
- 3008868758
- 1928237
- 3025349506
- 3016592765
- 3017367014
- 3017636737
- 3009134855
- 3006154292
- 9611102
- 3007532396
- 3004361445
- 3004040397
- 3010220595
- 3013497507
- 9614969
- 9614434
- 3003790304
- 9610773
- 1037007
- 3015552886
- 1221826
- 3004638277
- 3008386005
- 3025482817
- 2085947
- 3009039068
- 3042172882
- 1221934
- 2020550
- 3002808148
- 3014644276
- 3014055212
- 8010418
- 1045254
- 2242464
- 9610595
- 3025603301
- 1650907
- 2027009
- 3014769442
- 2518897
- 3002807315
- 3015967359
- 9515015
- 3016678045
- 3006546082
- 3003418325
- 9611668
Source Documents
510(k) summary PDF not indicated by FDA
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