NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900— 510(k) K983219

Name: FDA 510(k) clearance K983219
Creator: U.S. Food and Drug Administration
Published: 1998-12-07

Substantially Equivalent

Drager, Inc.

FDA 510(k) clearance K983219 for NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900, Substantially Equivalent on 1998-12-07. Applicant: Drager, Inc.. Device class: 2.

Clearance details

Applicant: Drager, Inc.
Product code: Code CBK
Device class: Class 2
Regulation: 21 CFR 868.5895
Advisory panel: Anesthesiology
Date received: 1998-09-14
Decision date: 1998-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Telford, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBK

view all

K253647 — Evita (V800); Evita (V600)2026-05-07
K252663 — Inbentus Versatile2026-04-14
K251888 — VPAP Pediatric Face Mask2026-03-12
K232365 — Vivo 45 LS2025-12-19
K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A) +3 more2025-09-10

More clearances from Drager, Inc.

view all

K992608 — ATC OPTION FOR EVITA 2 DURA AND EVITA 41999-08-24
K984577 — DRAGER OXYLOG 20001999-01-22
K982789 — MEDICAL AIR COMPRESSOR, MODEL # 84134191998-10-29
K980642 — EVITA 4 (8411900)1998-09-04
K974176 — BABYLOG 8000 PLUS1998-06-17

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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