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FDA 510(k)

ABBY II PATIENT MONITOR OR VITAL SIGNS M

K-Number: K801515 · 1980-07-08

ApplicantAbbott Medical Electronics Co.
Decision Date1980-07-08
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ABBY II PATIENT MONITOR OR VITAL SIGNS M is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Medical Electronics Co.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801515. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBY II PATIENT MONITOR OR VITAL SIGNS M?

ABBY II PATIENT MONITOR OR VITAL SIGNS M is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Abbott Medical Electronics Co.. The 510(k) number is K801515.

When did ABBY II PATIENT MONITOR OR VITAL SIGNS M receive FDA 510(k) clearance?

ABBY II PATIENT MONITOR OR VITAL SIGNS M received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801515.

Who is the listed applicant for ABBY II PATIENT MONITOR OR VITAL SIGNS M?

The FDA 510(k) record lists Abbott Medical Electronics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABBY II PATIENT MONITOR OR VITAL SIGNS M?

The FDA product code for ABBY II PATIENT MONITOR OR VITAL SIGNS M is DRT.

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 Abbott Medical Electronics Co. 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.

K790304PREAMPLIFIER MODULE, EKG RESPIRATION

Related Devices (Code: DRT)

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

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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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