PFT GASES— 510(k) K781523

Substantially Equivalent

Gardner Cryogenics

FDA 510(k) clearance K781523 for PFT GASES, Substantially Equivalent on 1978-12-01. Applicant: Gardner Cryogenics. Device class: 1.

Clearance details

Applicant: Gardner Cryogenics
Product code: Code BXY
Device class: Class 1
Regulation: 21 CFR 868.2350
Advisory panel: Anesthesiology
Date received: 1978-09-05
Decision date: 1978-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BXY

K953506 — WESTMED RESPIRATORY LUER ADAPTOR1995-09-15
K902916 — PRECISION MEDICAL NEB BLOCK1990-07-23
K902917 — PRECISION MEDICAL ELIMINATOR1990-07-23
K863510 — OXY-OFF(TM)1986-10-22
K860516 — LSP MINILATOR1986-02-21

More clearances from Gardner Cryogenics

K770494 — BLOOD GAS ANALYZER-CALIBRATION GAS1977-04-15

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