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
