510(k) K033146
- Device
- TONO-PEN TONOMETER TIP COVER
- Applicant
- TRA & ACCESSORIES
- 510(k) number
- K033146
- Product code
- HKY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-11-23
- Date received
- 2003-09-30
- Regulation
- 886.1930
- Classification name
- Tonometer, Manual
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD MASTROLEO
- Address
- 449 W. Allen Ave. Suite 107 San Dimas CA US 91773 91773
FDA Registration Numbers#
- 1000176188
- 3010155661
- 3003617485
- 3004950803
- 3007744213
- 3005324856
- 8010482
- 3009173773
- 3038356864
- 3009576895
- 3004095901
- 3003418325
- 1836161
- 1319721
- 3014865
- 9710516
- 3005785090
- 2219920
- 8044131
- 2080939
- 3004215117
- 1226586
- 3011223751
- 9611112
- 3009496855
- 3011898560
- 3019907057
- 2031962
- 3005528784
- 2431166
- 3002894792
- 1313525
- 3006550126
- 3005906810
- 3005809810
- 1721676
- 3015972897
- 9616517
- 3004681519
- 2245590
- 3005755367
- 3009756153
- 3015177648
- 1527493
- 3008132398
- 3012375451
- 3008770252
- 3010610157
- 8020986
- 3010227033
- 3010399798
- 9616199
- 2521877
- 1000391004
- 3015895045
- 1225798
- 3012302888
- 1932180
- 2245304
- 1526534
- 3004441848
- 2242450
- 3010383847
- 3010287677
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HKY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241447 | iCare ST500 (TA04) | Icare Finland OY | 2024-09-27 |
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | Reichert, Inc. | 2024-05-01 |
| K234037 | CATS-L Tonometer™ Prism | Cats Tonometer, LLC | 2024-02-09 |
| K232143 | Applanation Tonometer HT-5000 | Huvitz Co., Ltd. | 2023-10-23 |
| K220852 | iCare IC200 | Icare Finland OY | 2022-10-06 |
| K211355 | iCare HOME2 | Icare Finland OY | 2022-01-25 |
| K203850 | CATS®-D Tonometer Prism | Cats Tonometer, LLC | 2021-06-14 |
| K200966 | Icare HOME Tonometer | Icare Finland OY | 2020-05-07 |
| K190316 | Icare ic200 | Icare Finland OY | 2020-01-14 |
| K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2019-12-19 |
| K182491 | Applanation tonometer AT-2 | Takagi Seiko Co., Ltd. | 2018-12-10 |
| K180839 | AT 030 | Carl Zeiss Meditec, AG | 2018-06-07 |
| K173904 | CATS Tonometer Prism | Cats Tonometer, LLC | 2018-03-09 |
| K172728 | Applanation tonometer AT-1 | Takagi Seiko Co., Ltd. | 2017-10-17 |
| K163343 | Icare HOME tonometer | Icare Finland OY | 2017-03-21 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases