Product code BTK— Anesthesiology

FDA has cleared 6 devices under product code BTK between 1981 and 1994, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19941 clearance
• 19921 clearance
• 19852 clearances
• 19831 clearance
• 19811 clearance

• Vital Signs, Inc.2 clearances
• Respironics, Inc.1 clearance
• Medovations, Inc.1 clearance
• Medipart Jerry Alexander1 clearance
• Life Design Systems, Inc.1 clearance

• K944949 — GENERAL ANESTHESIA SYSTEMVital Signs, Inc.·1994-11-14
• K914335 — STRAP, HEAD, GAS MASKVital Signs, Inc.·1992-04-02
• K854537 — HEADSTRAPLife Design Systems, Inc.·1985-12-03
• K853573 — MEDIPART FACE MASK HEADSTRAP MP-9100Medipart Jerry Alexander·1985-10-29
• K831008 — HEAD STRAPMedovations, Inc.·1983-05-09
• K810991 — HEADSTRAPRespironics, Inc.·1981-04-29