510(k) K001995

SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER by Qrs Diagnostic, LLC — Product Code DQA

K001995 is an FDA 510(k) premarket notification submitted by Qrs Diagnostic, LLC for the device "SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on September 8, 2000. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Qrs Diagnostic, LLC has at least 6 other 510(k) clearances on record.