510(k) K844386

ESCOTEK-EST 301A ULTRA-SONIC UNIT by Nor-Am Patient Care Products, Inc. — Product Code IMI

K844386 is an FDA 510(k) premarket notification submitted by Nor-Am Patient Care Products, Inc. for the device "ESCOTEK-EST 301A ULTRA-SONIC UNIT". The FDA issued a decision of Substantially Equivalent on May 1, 1985. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. Nor-Am Patient Care Products, Inc. has 6 other 510(k) clearances on record.