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FDA 510(k)

PICTOOLS MEDICAL TOOL KIT MODEL 1.0

K-Number: K982146 · 1998-09-14

ApplicantPegasus Imaging Corp.
Decision Date1998-09-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PICTOOLS MEDICAL TOOL KIT MODEL 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Pegasus Imaging Corp.. It received FDA 510(k) clearance on 1998-09-14 under 510(k) number K982146. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICTOOLS MEDICAL TOOL KIT MODEL 1.0?

PICTOOLS MEDICAL TOOL KIT MODEL 1.0 is a medical device that received FDA 510(k) clearance on 1998-09-14. The listed applicant is Pegasus Imaging Corp.. The 510(k) number is K982146.

When did PICTOOLS MEDICAL TOOL KIT MODEL 1.0 receive FDA 510(k) clearance?

PICTOOLS MEDICAL TOOL KIT MODEL 1.0 received FDA 510(k) clearance on 1998-09-14, under 510(k) number K982146.

Who is the listed applicant for PICTOOLS MEDICAL TOOL KIT MODEL 1.0?

The FDA 510(k) record lists Pegasus Imaging Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PICTOOLS MEDICAL TOOL KIT MODEL 1.0?

The FDA product code for PICTOOLS MEDICAL TOOL KIT MODEL 1.0 is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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