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FDA 510(k)

ORS-100

K-Number: K921568 · 1992-06-09

ApplicantMnlase, Inc.
Decision Date1992-06-09
Product CodeJRM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ORS-100 is the device name listed in this FDA 510(k) record. The listed applicant is Mnlase, Inc.. It received FDA 510(k) clearance on 1992-06-09 under 510(k) number K921568. The device is classified under product code JRM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORS-100?

ORS-100 is a medical device that received FDA 510(k) clearance on 1992-06-09. The listed applicant is Mnlase, Inc.. The 510(k) number is K921568.

When did ORS-100 receive FDA 510(k) clearance?

ORS-100 received FDA 510(k) clearance on 1992-06-09, under 510(k) number K921568.

Who is the listed applicant for ORS-100?

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

What is the FDA product code for ORS-100?

The FDA product code for ORS-100 is JRM.

Other records listing Mnlase, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K944630MODEL 230-SAS LASER DELIVERY PROBEK944625MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASERK944470CURVED ENDOPHOTOCOAGULATOR LASER PROBEK944628MODEL 220-SS LASER DELIVERY PROBEK944471STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBEK944629MODEL 230-SAC LASER DELIVERY PROBE

View all 22 devices →

Related Devices (Code: JRM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K921569ORS-200Mnlase, Inc.K921570ORS-300Mnlase, Inc.K915427ORS-1000Mnlase, Inc.K913777SELF-CONTAINED SURGICAL SLUSH FREEZERTaylor Corp.K894006SANISERV SURGICAL SLUSH SYSTEMSaniserv, Inc.K782077LANCER ICE CUBESherwood Medical Industries

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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