510(k) K781500
- Device
- Model 845t Imaging/ergometer Table
- Applicant
- QUINTON, INC.
- 510(k) number
- K781500
- Product code
- JYZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-09-14
- Date received
- 1978-08-30
- Regulation
- 874.4420
- Classification name
- Rod, Measuring Ear
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 8010099
- 8030607
- 3004608878
- 9613926
- 1417592
- 3036795921
- 3012995405
- 3002858762
- 1421879
- 3013497507
- 9680837
- 3021680161
- 3005809810
- 3011137372
- 1421101
- 3010041511
- 3003418325
- 8040278
- 8010372
- 1057946
- 3005440795
- 9611112
- 3007137643
- 1836161
- 1923569
- 9610905
- 3014334038
- 1056350
- 3005528784
- 3008770252
- 2916714
- 9613083
Source Documents#
510(k) summary PDF not indicated by FDA