510(k) K920379

NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX by Novametrix Medical Systems, Inc. — Product Code DQA

K920379 is an FDA 510(k) premarket notification submitted by Novametrix Medical Systems, Inc. for the device "NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX". The FDA issued a decision of Substantially Equivalent on July 15, 1992. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Novametrix Medical Systems, Inc. has at least 10 other 510(k) clearances on record.