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FDA 510(k)

KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES

K-Number: K972488 · 1998-01-22

ApplicantKarl Storz Endoscopy
Decision Date1998-01-22
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy. It received FDA 510(k) clearance on 1998-01-22 under 510(k) number K972488. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES?

KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1998-01-22. The listed applicant is Karl Storz Endoscopy. The 510(k) number is K972488.

When did KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES receive FDA 510(k) clearance?

KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES received FDA 510(k) clearance on 1998-01-22, under 510(k) number K972488.

Who is the listed applicant for KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES?

The FDA 510(k) record lists Karl Storz Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES?

The FDA product code for KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES is HET.

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Related Devices (Code: HET)

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Official Source

View on FDA Database →

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

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