MEGAPULSE II— 510(k) K973732

Substantially Equivalent

Pti

FDA 510(k) clearance K973732 for MEGAPULSE II, Substantially Equivalent on 1998-01-23. Applicant: Pti. Device class: 2.

Clearance details

Applicant: Pti
Product code: Code IMJ
Device class: Class 2
Regulation: 21 CFR 890.5290
Advisory panel: Physical Medicine
Date received: 1997-09-30
Decision date: 1998-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Topeka, KS, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IMJ

K252963 — BTL-899TT2026-06-12
K250376 — ViVY2025-11-05
K243112 — Curapuls 6702025-06-25
K223620 — Reprieve by RegenesisTM2023-05-24
K182363 — BTL-7032019-01-24

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