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FDA 510(k)

ACUSYST-JR

K-Number: K872086 · 1987-06-15

ApplicantEndotronics, Inc.
Decision Date1987-06-15
Product CodeKJH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACUSYST-JR is the device name listed in this FDA 510(k) record. The listed applicant is Endotronics, Inc.. It received FDA 510(k) clearance on 1987-06-15 under 510(k) number K872086. The device is classified under product code KJH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUSYST-JR?

ACUSYST-JR is a medical device that received FDA 510(k) clearance on 1987-06-15. The listed applicant is Endotronics, Inc.. The 510(k) number is K872086.

When did ACUSYST-JR receive FDA 510(k) clearance?

ACUSYST-JR received FDA 510(k) clearance on 1987-06-15, under 510(k) number K872086.

Who is the listed applicant for ACUSYST-JR?

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

What is the FDA product code for ACUSYST-JR?

The FDA product code for ACUSYST-JR is KJH.

Related Clinical Trials

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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Other records listing Endotronics, 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.

K875151ACUSYST-P/3XK864334ACUSYST-P (CELL CULTURE EQUIPMENT)

Related Devices (Code: KJH)

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.

K875151ACUSYST-P/3XEndotronics, Inc.K864334ACUSYST-P (CELL CULTURE EQUIPMENT)Endotronics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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