STERILIZED OMNI GEL— 510(k) K872519

Substantially Equivalent

Echo Ultrasound

FDA 510(k) clearance K872519 for STERILIZED OMNI GEL, Substantially Equivalent on 1987-08-03. Applicant: Echo Ultrasound. Device class: 2.

Clearance details

Applicant: Echo Ultrasound
Product code: Code JOT
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1987-06-25
Decision date: 1987-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewistown, PA, US

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Recent devices under product code JOT

K923647 — RFG-DGP DISPOSABLE GROUNDING PADS1992-11-09
K905545 — ULTRASOUND TRANSMISSION GEL1991-03-29
K904418 — ULTRASOUND COUPLING GEL1991-02-11
K901217 — TRIA-SONIC ULTRA SOUND TRANSMISSION GEL1990-06-22
K894490 — STERILE ULTRASOUND TRANSMISSION GEL1989-10-05

More clearances from Echo Ultrasound

K924054 — PHONOCARDIOGRAPH1993-01-22
K903414 — TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN1990-09-19
K893225 — COUPLANT WARMING DEVICE1989-10-12
K844034 — SONOCARE1985-01-23
K844120 — ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS1985-01-23

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