510(k) K760972
- Device
- TYCOS DIAGNOSTIC PENLIGHT
- Applicant
- Taylor Instrument Analytics Co.
- 510(k) number
- K760972
- Product code
- KYT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-01-26
- Date received
- 1976-11-04
- Regulation
- 880.6350
- Classification name
- Light, Examination, Medical, Battery Powered
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2018957
- 3006252153
- 3033882233
- 2020550
- 3008494300
- 3014902417
- 3015745029
- 9610612
- 3005460813
- 3003418325
- 3005374252
- 3026861828
- 3021839632
- 1643817
- 3009308092
- 3007421149
- 2081040
- 3006179052
- 3012777736
- 3014739961
- 9680721
- 3036795926
- 3012187697
- 3033433849
- 1528142
- 8040278
- 3012776156
- 1718873
- 3020777598
- 3015316279
- 3003622639
- 3014414462
- 3023339256
- 3027187888
- 3008858073
- 3013403214
- 3025376090
- 9680874
- 3010393950
- 3007594755
- 1834177
- 3003674698
- 3004598675
- 9680718
- 9617655
- 3009424883
- 1211998
- 9681758
- 3005951403
- 3006984716
- 2434008
- 3008485841
- 3007532396
- 3006113277
- 1836161
- 3023388535
- 3030516433
- 3012541976
- 3004168759
- 2434839
- 1035166
- 3006551266
- 3006621353
- 3008496560
- 1054713
- 3003782614
- 3011707917
- 3011611571
- 3001650535
- 3004215117
- 3006223081
- 3008264111
- 3035374295
- 3042172872
- 3011669217
- 3045058049
- 3018016862
- 3027499529
- 3011644607
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KYT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K920782 | OLYMPIC TRANS-LITE | Olympic Medical Corp. | 1992-03-27 |
| K841588 | SUN-LITE WHITE SPOT | Suncoast Medical Manufacturers, Inc. | 1984-05-22 |
| K841589 | C-LITE | Suncoast Medical Manufacturers, Inc. | 1984-05-22 |
| K791001 | PENLIGHT/SWAB HOLDER | Concept, Inc. | 1979-06-22 |
| K781228 | PENLIGHTS | Abco Dealers, Inc. | 1978-09-07 |