Sep

2003

Consolidated Machine Corp.

Company: Consolidated Machine Corp.
Product: Steam sterilizers
Date: 9/24/03

Our inspection confirmed that in 1994 your firm introduced the Mark V microprocessor that is marketed as an attachment to all of your approximately fourteen steam sterilizers. This microprocessor is software driven and controls the time and temperature of the sterilization cycles. This microprocessor addition constitutes a significant change in design technology, which could affect the safety or effectiveness of the device. This modification requires the submission of a premarket notification (510(k)) to FDA as described under Title 21 Code of Federal Regulations (21 CFR) part 807.81(a)(3)(i).

FDA District: New England District Office

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Consolidated Machine Corp.

Amy Sellers

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