SIGMOID TONOMITOR— 510(k) K890466

Substantially Equivalent

Tonometrics, Inc.

FDA 510(k) clearance K890466 for SIGMOID TONOMITOR, Substantially Equivalent on 1989-04-21. Applicant: Tonometrics, Inc.. Device class: 2.

Clearance details

Applicant: Tonometrics, Inc.
Product code: Code GBT
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1989-01-31
Decision date: 1989-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GBT

K941391 — INFLATABLE RETENTION CUFF SPECULUM1994-10-20
K924549 — TRI-MED QUICK-STEP(TM) RECTAL TUBE1994-02-10

More clearances from Tonometrics, Inc.

K920849 — TRIP CIC CATHETER1995-03-17
K911825 — TRIP(TM) NASOGASTRIC SUMP CATHETER1991-07-23
K883234 — TONOMITOR (TM) + SUMP1988-10-12

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