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FDA 510(k)

SERUM AMMONIA CONTROL

K-Number: K935606 · 1994-03-22

ApplicantP.T. Meditrol
Decision Date1994-03-22
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM AMMONIA CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is P.T. Meditrol. It received FDA 510(k) clearance on 1994-03-22 under 510(k) number K935606. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERUM AMMONIA CONTROL?

SERUM AMMONIA CONTROL is a medical device that received FDA 510(k) clearance on 1994-03-22. The listed applicant is P.T. Meditrol. The 510(k) number is K935606.

When did SERUM AMMONIA CONTROL receive FDA 510(k) clearance?

SERUM AMMONIA CONTROL received FDA 510(k) clearance on 1994-03-22, under 510(k) number K935606.

Who is the listed applicant for SERUM AMMONIA CONTROL?

The FDA 510(k) record lists P.T. Meditrol as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERUM AMMONIA CONTROL?

The FDA product code for SERUM AMMONIA CONTROL is JJX.

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Other records listing P.T. Meditrol 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: JJX)

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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