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FDA 510(k)

ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M

K-Number: K852947 · 1986-01-06

Decision Date1986-01-06
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Laboratories, Inc.. It received FDA 510(k) clearance on 1986-01-06 under 510(k) number K852947. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M?

ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M is a medical device that received FDA 510(k) clearance on 1986-01-06. The listed applicant is Advanced Technology Laboratories, Inc.. The 510(k) number is K852947.

When did ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M receive FDA 510(k) clearance?

ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M received FDA 510(k) clearance on 1986-01-06, under 510(k) number K852947.

Who is the listed applicant for ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M?

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

What is the FDA product code for ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M?

The FDA product code for ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M is ITX.

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.

Other records listing Advanced Technology Laboratories, 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.

View all 61 devices →

Related Devices (Code: ITX)

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.

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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