CO2 LASER— 510(k) K801197

Substantially Equivalent

Advanced Biomedical Instruments

FDA 510(k) clearance K801197 for CO2 LASER, Substantially Equivalent on 1980-06-30. Applicant: Advanced Biomedical Instruments. Device class: 2.

Clearance details

Applicant: Advanced Biomedical Instruments
Product code: Code HHR
Device class: Class 2
Regulation: 21 CFR 884.4550
Advisory panel: Obstetrics/Gynecology
Date received: 1980-05-19
Decision date: 1980-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HHR

K881507 — ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES1989-04-27
K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE1988-08-22
K875314 — GL-35 COLPOSCOPIC LASER SYSTEM1988-08-05
K874615 — LASER CANNISTER FILTER1988-06-23
K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE1988-06-01

More clearances from Advanced Biomedical Instruments

K843156 — BIOLAS YAG 100 CILAS, ERCELAS YAG 1001984-10-01
K842670 — BIOLAS YAG 1001984-08-08
K820519 — BIOPSER1982-04-29

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