510(k) K063310
- Device
- TRUEFIELD ANALYZER
- Applicant
- SEEING MACHINES LIMITED
- 510(k) number
- K063310
- Product code
- HPT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-08-02
- Date received
- 2006-11-02
- Regulation
- 886.1605
- Classification name
- Perimeter, Automatic, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALAN DONALD
- Address
- 11440 W. Bernardo Ct. Suite 300 San Diego CA US 92127 92127
FDA Registration Numbers#
- 3004441848
- 3008058195
- 9611269
- 3007913988
- 3030516069
- 1000431353
- 3033566
- 9616199
- 3005205657
- 3020410096
- 3005955744
- 3013575858
- 3008364787
- 3043041478
- 3016965632
- 8030392
- 3030089778
- 3038287496
- 3014175039
- 3018501318
- 3017045523
- 1836161
- 3004594297
- 3016965602
- 3017657497
- 3031081959
- 3011898560
- 3003951061
- 3043366321
- 3041277555
- 3004574050
- 3014397047
- 3014399865
- 3010082909
- 2936921
- 3005301392
- 3015867300
- 3005785090
- 1000176188
- 3008422902
- 3006853861
- 3030491936
- 3015005532
- 2918630
- 3009973692
- 3004103096
- 3002807715
- 3017784352
- 3013403214
- 3011223751
- 3020309552
- 8030607
- 3009578732
- 3020723591
- 3007673896
- 3020246591
- 3010610157
- 3027499529
- 3013436538
- 3029582873
- 3013158193
- 3008312728
- 3011442035
- 3017591190
- 3014400613
- 2031962
- 3010394097
Source Documents#
Other 510(k) Records For Product Code HPT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K092187 | MAIA, MODEL 1 | Centervue S.P.A. | 2010-05-27 |
| K093213 | GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES | Carl Zeiss Meditec, Inc. | 2010-03-12 |
| K091579 | FORESEE HOME | Notal Vision , Ltd. | 2009-12-23 |
| K050350 | THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) | Notal Vision, Inc. | 2005-04-29 |
| K023623 | NOVAVISION, MODEL 2.0 | Novavision, Inc. | 2003-04-22 |
| K971156 | KASHA VISUAL FIELD SYSTEM | Kasha Software, Inc. | 1997-05-28 |
| K961090 | AUTOMATIC VISUAL FIELD PLOTTER AP-125 | Kowa Optimed, Inc. | 1996-06-17 |
| K954167 | HUMPHREY FIELD ANALYZER (HFA II) | Carl Zeiss, Inc. | 1995-11-24 |
| K954037 | FIELD TREND | Synemed, Inc. | 1995-11-17 |
| K943234 | MS-30 AUTOMATIC PERIMETER | Marco Ophthalmic, Inc. | 1994-07-27 |
| K932258 | OPTICOM M600 | Clement Clarke, Inc. | 1994-07-25 |
| K930937 | LD 400 | Vismed, Inc. | 1993-10-18 |
| K922294 | PERIKON PCL 90 | Optikon Oftalmologia Spa | 1993-01-28 |
| K902878 | MT-336 AUTOMATIC PERIMETER | Marco Technologies | 1990-09-18 |
| K884867 | OPTIFIELD I AND II AUTOMATED PERIMETERS | Optimed, Inc. | 1989-03-09 |
Legacy Summary#
summary
FDA Review#
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