ClearanceBrief
510(k) K172702 ยท CAD Vaporizer, Anesthesia, Non-Heated

Tec 820, Tec 850

ApplicantDatex-Ohmeda, Inc., Madison WI, US
DecisionSubstantially Equivalent, Jan 4, 2018
ReceivedSep 7, 2017
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K172702

DateFirm and productCodeLinked 510(k)
Jan 7, 2025GE Medical Systems, LLC
Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
Open, Classified
CADNone listed
Jan 7, 2025GE Medical Systems, LLC
Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
Open, Classified
CADNone listed
Jan 7, 2025GE Medical Systems, LLC
Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
Open, Classified
CADNone listed
Jan 7, 2025GE Medical Systems, LLC
Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
Open, Classified
CADNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.