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FDA 510(k)

GAMBRO PRESSURE MONITOR PRM 10

K-Number: K822822 · 1982-10-18

ApplicantGambro, Inc.
Decision Date1982-10-18
Product CodeDXS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GAMBRO PRESSURE MONITOR PRM 10 is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1982-10-18 under 510(k) number K822822. The device is classified under product code DXS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMBRO PRESSURE MONITOR PRM 10?

GAMBRO PRESSURE MONITOR PRM 10 is a medical device that received FDA 510(k) clearance on 1982-10-18. The listed applicant is Gambro, Inc.. The 510(k) number is K822822.

When did GAMBRO PRESSURE MONITOR PRM 10 receive FDA 510(k) clearance?

GAMBRO PRESSURE MONITOR PRM 10 received FDA 510(k) clearance on 1982-10-18, under 510(k) number K822822.

Who is the listed applicant for GAMBRO PRESSURE MONITOR PRM 10?

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

What is the FDA product code for GAMBRO PRESSURE MONITOR PRM 10?

The FDA product code for GAMBRO PRESSURE MONITOR PRM 10 is DXS.

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Other records listing Gambro, Inc. as applicant

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Related Devices (Code: DXS)

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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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