510(k) clearances

P200TE (A10700)

Optos Plc. · Ophthalmic

K233602Substantially EquivalentTraditionalOBO
Open FDA's page for this record
Third party flag
N
City
Dunfermline
Advisory committee description
Ophthalmic
Address 1
Queensferry House
Address 2
Carnegie Campus, Enterprise Way
Statement or summary
Summary
Product code
OBO
Zip code
KY11 8GR
Applicant
Optos Plc.
Decision date
2024-05-09
Decision code
SESE
Country code
GB
Device name
P200TE (A10700)
Advisory committee
OP
Contact
Graham McLeod
K number
K233602
Date received
2023-11-09
Review advisory committee
OP
Postal code
KY11 8GR
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Tomography, Optical Coherence
Medical specialty description
Ophthalmic
Regulation number
886.1570
Device class
2
Registration number
9616199, 8030392, 8043762, 3009746052, 3005744933, 3038356864, 9611269, 3038614464, 9615030, 3013403214, 3003589956, 3020723591, 3005950902, 2918630, 3008729548, 9615010, 1054713, 3002807715, 1000181430, 1000204638, 9614661, 9614730, 3010000450, 3004441848, 2936921, 3033566, 9617167, 3004026651, 3008348697, 2242863, 8020986
FEI number
3009746052, 3005744933, 3038356864, 3038614464, 3013403214, 3003589956, 3020723591, 3001362763, 3005950902, 1000175127, 2918630, 1000114111, 3008729548, 3002680900, 1000582291, 3002807715, 1000181430, 1000204638, 3002807157, 3002785343, 3010000450, 3003768492, 3002807782, 3004441848, 2936921, 3008348697, 4196, 3003481798, 3003060634, 2242863
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.