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FDA 510(k)

MONI-TROL(R)

K-Number: K891929 · 1989-05-09

ApplicantBaxter Healthcare Corp
Decision Date1989-05-09
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MONI-TROL(R) is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1989-05-09 under 510(k) number K891929. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONI-TROL(R)?

MONI-TROL(R) is a medical device that received FDA 510(k) clearance on 1989-05-09. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K891929.

When did MONI-TROL(R) receive FDA 510(k) clearance?

MONI-TROL(R) received FDA 510(k) clearance on 1989-05-09, under 510(k) number K891929.

Who is the listed applicant for MONI-TROL(R)?

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

What is the FDA product code for MONI-TROL(R)?

The FDA product code for MONI-TROL(R) is JJY.

Other records listing Baxter Healthcare 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.

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Related Devices (Code: JJY)

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

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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