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FDA 510(k)

SCMD-1000

K-Number: K980985 · 1998-05-01

ApplicantHoward Instruments, Inc.
Decision Date1998-05-01
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SCMD-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Howard Instruments, Inc.. It received FDA 510(k) clearance on 1998-05-01 under 510(k) number K980985. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCMD-1000?

SCMD-1000 is a medical device that received FDA 510(k) clearance on 1998-05-01. The listed applicant is Howard Instruments, Inc.. The 510(k) number is K980985.

When did SCMD-1000 receive FDA 510(k) clearance?

SCMD-1000 received FDA 510(k) clearance on 1998-05-01, under 510(k) number K980985.

Who is the listed applicant for SCMD-1000?

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

What is the FDA product code for SCMD-1000?

The FDA product code for SCMD-1000 is HNO.

Other records listing Howard Instruments, 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.

K063104FOX MEDICAL DIODE LASER SYSTEM 810NMK030948VMATE MODEL VMM1000K974598MICROKERATOME OR THE MATEK972727CBALK-1000 BLADE

Related Devices (Code: HNO)

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.

K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.K172994EPI K ConsoleMoria SAK072102EPIVISION SL SYSTEMGebauer Medizintechnik GmbHK082043CARRIAZO-PENDULAR MICROKERATOMESchwind Eye-Tech-Solutions GmbH & Co. KGK062465ZYOPTIX XP EPI SEPARATOR SYSTEMBausch & Lomb, Inc.K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEMHawken 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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