510(k) K232567
- Device
- Myriad SPECTRA Light Source
- Applicant
- Nico Corporation
- 510(k) number
- K232567
- Product code
- QFX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-03-14
- Date received
- 2023-08-24
- Regulation
- 882.4950
- Classification name
- Diagnostic Neurosurgical Microscope Filter
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Megan Becker
- Address
- 250 E 96th St. Suite 125 Indianapolis IN US 46240 46240
FDA Registration Numbers#
- 3007456622
- 9615010
- 3010126772
- 3003974370
- 3015967359
- 3043527620
- 1000204638
Source Documents#
Other 510(k) Records For Product Code QFX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251286 | Affirm 400 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2026-01-21 |
| K240215 | BLUE 400; BLUE 400 S | Carl Zeiss Meditec, AG | 2024-06-28 |
| K211346 | BLUE 400 | Carl Zeiss Meditec, AG | 2022-07-22 |
| DEN180024 | Leica FL400 | Leica Microsystems (Schweiz) AG | 2019-03-28 |