SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS

SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS is an FDA 510(k)-cleared medical device (K890547) manufactured by Pacesetter Systems. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on March 21, 1989. Regulation: 8.