510(k) K220929
- Device
- Excelsior
- Applicant
- Merit Cro, Inc.
- 510(k) number
- K220929
- Product code
- NFJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-10-31
- Date received
- 2022-03-31
- Regulation
- 892.2050
- Classification name
- System, Image Management, Ophthalmic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Yijuan Huang
- Address
- 6527 Normandy Ln. Suite 100 Madison WI US 53719 53719
FDA Registration Numbers
- 1000176188
- 2242863
- 3002807715
- 3011520729
- 3014606890
- 3038356864
- 3014655548
- 3038614464
- 3010197300
- 3012256561
- 2433682
- 2183926
- 3011223751
- 9615030
- 8030392
- 3014926240
- 1316463
- 3016735536
- 3003995303
- 3008729548
- 9614661
- 2918630
- 9617167
- 3009746052
- 3009422347
- 2936921
- 9616199
- 3004026651
- 9615010
- 3008422902
- 1000181430
- 9680854
Source Documents
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| K200385 | CONTINUUM PACS | Integrated Ophthalmic Systems, Inc. | 2020-03-16 |
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