FDA 510(k)

PCM 2000; ISOLAIR APR MODEL 2735

K-Number: K970448 · 1997-04-30

Decision Date1997-04-30

Product CodeMSH

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

PCM 2000; ISOLAIR APR MODEL 2735 is the device name listed in this FDA 510(k) record. The listed applicant is Tecnol Medical Products, Inc.. It received FDA 510(k) clearance on 1997-04-30 under 510(k) number K970448. The device is classified under product code MSH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCM 2000; ISOLAIR APR MODEL 2735?

PCM 2000; ISOLAIR APR MODEL 2735 is a medical device that received FDA 510(k) clearance on 1997-04-30. The listed applicant is Tecnol Medical Products, Inc.. The 510(k) number is K970448.

When did PCM 2000; ISOLAIR APR MODEL 2735 receive FDA 510(k) clearance?

PCM 2000; ISOLAIR APR MODEL 2735 received FDA 510(k) clearance on 1997-04-30, under 510(k) number K970448.

Who is the listed applicant for PCM 2000; ISOLAIR APR MODEL 2735?

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

What is the FDA product code for PCM 2000; ISOLAIR APR MODEL 2735?

The FDA product code for PCM 2000; ISOLAIR APR MODEL 2735 is MSH.

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Other records listing Tecnol Medical Products, Inc. as applicant

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Related Devices (Code: MSH)

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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.