Product code LPP— Anesthesiology

HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275

Classification name
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
Device class
Class 2
Regulation
21 CFR 868.2500
Advisory panel
Anesthesiology
Total cleared
2
First cleared
Most recent

Market context for product code LPP

FDA has cleared 2 devices under product code LPP between 1989 and 2000, filed by 2 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.

Clearances per year

Top applicants under product code LPP

Recent clearances under product code LPP

Data sourced from openFDA. This site is unofficial and independent of the FDA.