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510(k) K214097

Explorer Air II by Surgvision GmbH — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2022
Date Received
December 28, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

Other clearances by Surgvision GmbH

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  • K231075 — Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (June 20, 2023)
  • K230727 — SPY Portable Handheld Imaging (SPY-PHI) System (June 5, 2023)
  • K222240 — EXPLORER AIR® II (February 28, 2023)
  • K202391 — DIR 800 (January 21, 2021)
  • K192761 — Asimov-MKS Imaging System (January 17, 2020)
  • K190772 — SURGICAL MICROSCOPE SYSTEM ORBEYE with IR (October 10, 2019)