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FDA 510(k)

OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE

K-Number: K943987 · 1994-12-07

ApplicantInnerspace Medical, Inc.
Decision Date1994-12-07
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE is the device name listed in this FDA 510(k) record. The listed applicant is Innerspace Medical, Inc.. It received FDA 510(k) clearance on 1994-12-07 under 510(k) number K943987. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE?

OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE is a medical device that received FDA 510(k) clearance on 1994-12-07. The listed applicant is Innerspace Medical, Inc.. The 510(k) number is K943987.

When did OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE receive FDA 510(k) clearance?

OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE received FDA 510(k) clearance on 1994-12-07, under 510(k) number K943987.

Who is the listed applicant for OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE?

The FDA 510(k) record lists Innerspace Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE?

The FDA product code for OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE is GWM.

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Official Source

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