Product code JAX— Anesthesiology

FDA has cleared 8 devices under product code JAX between 1977 and 2000, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20001 clearance
• 19921 clearance
• 19891 clearance
• 19851 clearance
• 19831 clearance
• 19811 clearance
• 19791 clearance
• 19771 clearance

• Research Development Corp.2 clearances
• Thoratec Laboratories Corp.1 clearance
• Spirometrics, Inc.1 clearance
• Sdi Diagnostics, Inc.1 clearance
• Peace Medical, Inc.1 clearance
• Medical Associated Services, Inc.1 clearance
• Biotrine Corp.1 clearance

• K990962 — FLOSENSE, MODEL 29-8010Sdi Diagnostics, Inc.·2000-01-07
• K921178 — PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHSMedical Associated Services, Inc.·1992-08-26
• K884464 — SPIROMETRICS MODEL 2200 SM200 FLOW SENSORSpirometrics, Inc.·1989-01-19
• K853085 — PAX METERPeace Medical, Inc.·1985-09-03
• K833265 — RESPIRATORY FLOW MODULEThoratec Laboratories Corp.·1983-11-28
• K812825 — FLO-COR IBiotrine Corp.·1981-10-26
• K791730 — RING-ORIFICE, TURBULENT FLOW PNEUMOTResearch Development Corp.·1979-11-16
• K770061 — VO RESPIRATORY PNEUMOTACHOGRAPHResearch Development Corp.·1977-01-14