510(k) clearances

CIRRUS™ HD-OCT Model 6000

Carl Zeiss Meditec, Inc. · Ophthalmic

K233933Substantially EquivalentTraditionalOBO
Open FDA's page for this record
Third party flag
N
City
Dublin
Advisory committee description
Ophthalmic
Address 1
5300 Central Pkwy.
Statement or summary
Summary
Product code
OBO
Zip code
94568
Applicant
Carl Zeiss Meditec, Inc.
Decision date
2024-05-17
Decision code
SESE
Country code
US
Device name
CIRRUS™ HD-OCT Model 6000
Advisory committee
OP
Contact
Vidita Desai
K number
K233933
State
CA
Date received
2023-12-14
Review advisory committee
OP
Postal code
94568
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.