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FDA 510(k)

THE ADVANCED OSMOMETER (3900)

K-Number: K965036 · 1997-02-20

ApplicantAdvanced Instruments, Inc.
Decision Date1997-02-20
Product CodeJJM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THE ADVANCED OSMOMETER (3900) is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Instruments, Inc.. It received FDA 510(k) clearance on 1997-02-20 under 510(k) number K965036. The device is classified under product code JJM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE ADVANCED OSMOMETER (3900)?

THE ADVANCED OSMOMETER (3900) is a medical device that received FDA 510(k) clearance on 1997-02-20. The listed applicant is Advanced Instruments, Inc.. The 510(k) number is K965036.

When did THE ADVANCED OSMOMETER (3900) receive FDA 510(k) clearance?

THE ADVANCED OSMOMETER (3900) received FDA 510(k) clearance on 1997-02-20, under 510(k) number K965036.

Who is the listed applicant for THE ADVANCED OSMOMETER (3900)?

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

What is the FDA product code for THE ADVANCED OSMOMETER (3900)?

The FDA product code for THE ADVANCED OSMOMETER (3900) is JJM.

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Other records listing Advanced 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.

K152776Glocyte Automated Cell Counter SystemK120631PATIENT MONITORK112465VITAL SIGNS MONITORK962056ADVANCED MICRO-OSMOMETER MODEL 3300K930526INTERMITTENT COMPRESSION SYSTEM MODEL 5000K925970MODEL 3D3 OSMOMETER

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Related Devices (Code: JJM)

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.

K962056ADVANCED MICRO-OSMOMETER MODEL 3300Advanced Instruments, Inc.K925970MODEL 3D3 OSMOMETERAdvanced Instruments, Inc.K911092OSMOMETER MODEL 2400Advanced Instruments, Inc.K873642OSMOMETER MODEL 110Advanced Instruments, Inc.K843997AO-10 AUTOMATED OSMOMETERbioMerieux, Inc.K842750OSMOTIC PRESSURE AUTO & STAT OM-6010Kyoto Diagnostics, 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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