FDA 510(k)

SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE

K-Number: K974039 · 1998-01-12

Decision Date1998-01-12

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE is the device name listed in this FDA 510(k) record. The listed applicant is Schwartz Electro-Optics, Inc.. It received FDA 510(k) clearance on 1998-01-12 under 510(k) number K974039. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE?

SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE is a medical device that received FDA 510(k) clearance on 1998-01-12. The listed applicant is Schwartz Electro-Optics, Inc.. The 510(k) number is K974039.

When did SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE receive FDA 510(k) clearance?

SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE received FDA 510(k) clearance on 1998-01-12, under 510(k) number K974039.

Who is the listed applicant for SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE?

The FDA 510(k) record lists Schwartz Electro-Optics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE?

The FDA product code for SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE is GEX. This falls under the Gastroenterology category.

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Other records listing Schwartz Electro-Optics, Inc. as applicant

K980710SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 DP ALEXANDRITE LASER SYSTEM K980313SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE K973867SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEM K973603SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM K971404SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER K953585SCHWARTZ ELECTRO-OPTICES, INC. TRILASE 2100/20 HOLMIUM LASER

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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.