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FDA 510(k)

THE NAUTILUS

K-Number: K961124 · 1996-04-19

ApplicantRand Scientific Corp.
Decision Date1996-04-19
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE NAUTILUS is the device name listed in this FDA 510(k) record. The listed applicant is Rand Scientific Corp.. It received FDA 510(k) clearance on 1996-04-19 under 510(k) number K961124. The device is classified under product code FZE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE NAUTILUS?

THE NAUTILUS is a medical device that received FDA 510(k) clearance on 1996-04-19. The listed applicant is Rand Scientific Corp.. The 510(k) number is K961124.

When did THE NAUTILUS receive FDA 510(k) clearance?

THE NAUTILUS received FDA 510(k) clearance on 1996-04-19, under 510(k) number K961124.

Who is the listed applicant for THE NAUTILUS?

The FDA 510(k) record lists Rand Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE NAUTILUS?

The FDA product code for THE NAUTILUS is FZE.

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Other records listing Rand Scientific Corp. 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.

K963856RAND NASAL PACKINGK961081SPIRIT RIDGE SILICONE CARVING BLOCKK961057DURALASTIC SHEETING IIK955777PMMA CLASICK961071THE MAGNUM CHIN IMPLANTK961072PEC IMPLANT

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Related Devices (Code: FZE)

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.

K241253Medicon Epiplating SystemCmf Medicon Surgical, Inc.K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd.K090803HANSON MEDICAL FACIAL IMPLANTSHanson Medical, Inc.K090630NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)Nobel Biocare ABK071018MONARCH NASAL IMPLANTHanson Medical, Inc.K041690MONARCH NASAL IMPLANTHanson Medical, Inc.

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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