Decision Date1998-06-05
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
MACH-SIGMA HANDPIECE, ULTRAPUSH is the device name listed in this FDA 510(k) record. The listed applicant is Nsk Nakanishi, Inc.. It received FDA 510(k) clearance on 1998-06-05 under 510(k) number K980162. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MACH-SIGMA HANDPIECE, ULTRAPUSH?
MACH-SIGMA HANDPIECE, ULTRAPUSH is a medical device that received FDA 510(k) clearance on 1998-06-05. The listed applicant is Nsk Nakanishi, Inc.. The 510(k) number is K980162.
When did MACH-SIGMA HANDPIECE, ULTRAPUSH receive FDA 510(k) clearance?
MACH-SIGMA HANDPIECE, ULTRAPUSH received FDA 510(k) clearance on 1998-06-05, under 510(k) number K980162.
Who is the listed applicant for MACH-SIGMA HANDPIECE, ULTRAPUSH?
The FDA 510(k) record lists Nsk Nakanishi, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MACH-SIGMA HANDPIECE, ULTRAPUSH?
The FDA product code for MACH-SIGMA HANDPIECE, ULTRAPUSH is EFB.
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Other records listing Nsk Nakanishi, 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.
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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.