ELC-THERMO-SYSTEM— 510(k) K770678

Substantially Equivalent

Cutter Laboratories, Inc.

FDA 510(k) clearance K770678 for ELC-THERMO-SYSTEM, Substantially Equivalent on 1977-05-25. Applicant: Cutter Laboratories, Inc.. Device class: 3.

Clearance details

Applicant: Cutter Laboratories, Inc.
Product code: Code KXZ
Device class: Class 3
Regulation: 21 CFR 884.2982
Advisory panel: Obstetrics/Gynecology
Date received: 1977-04-11
Decision date: 1977-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KXZ

K851034 — NOVATHERM1985-09-27
K843124 — Q-SCAN THERMOGRAPHY SYSTEM1984-11-29
K832731 — BREAST & BODY HEALTH SYSTEM 20001984-01-30
K813547 — THERMASCAN1982-03-12
K781916 — FLEXT-THERM1979-02-02

More clearances from Cutter Laboratories, Inc.

K861315 — HYPERBARIC PENETRATION EXTENSION SET1986-05-21
K854106 — BAYSILEX1986-03-17
K842324 — PERFOURM1984-11-09
K834106 — INTRAVENOUS INFUSION CONTROLLER1984-05-30
K832237 — ORTHOPEDIC CASTING TAPE MAXCAST1983-08-16

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