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#
- 9680671
- 3009103001
- 3004168759
- 3021839632
- 3013421458
- 3005956028
- 3008264242
- 3006621353
- 3008494300
- 3015069921
- 3011499367
- 3003418325
- 3038356864
- 1017294
- 3012541976
- 3002562003
- 3013685983
- 3004598675
- 3027499529
- 1319721
- 3016489998
- 8010704
- 3009745997
- 1319639
- 3015438293
- 3008858073
- 3015316279
- 2434008
- 3014739961
- 3006799849
- 3011707917
- 3009308092
- 3013403214
- 3012678246
- 3005515469
- 1930126
- 1526854
- 3003622639
- 3004905643
- 3010774780
- 3038624873
- 3006210673
- 3017026146
- 3006252153
- 3013466775
- 3006113277
- 8010482
- 3030516433
- 3010393950
- 3005034064
- 9681758
- 3012314549
- 3008105001
- 3012776156
- 2081040
- 1035166
- 8040510
- 3015422337
- 1062671
- 1834177
- 2018957
- 9617655
- 2020550
- 1643817
- 3003452144
- 3017573591
- 3006179052
- 9680721
- 3012777736
- 3010374920
- 3007594755
- 1211998
- 3009424883
- 9610612
- 3010202439
- 3024680050
- 3002807209
- 1836161
- 3009512503
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 |