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Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K191027Ref 6887900

by Maquet Critical Care AB

Identity

Trade Name
Flow-e EUDAMED
Flow-e Anesthesia System FDA UDI
Generic Name
Anaesthesia workstation, general-purpose FDA UDI
Device Name
Flow Family EUDAMED
Model / Reference
6887900 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
07325710010457 EUDAMEDFDA UDI
Basic UDI-DI
73257100013485 EUDAMED
Direct Marketing DI
07325710010457 EUDAMED
510(k) Number
K191027 FDA 510(k)FDA UDI
FDA Product Code
BSZ FDA 510(k)FDA UDI
EMDN Code
Z1203010101 ANAESTHESIA DEVICES EUDAMED
GMDN Term
Anaesthesia workstation, general-purpose FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 868.5160 FDA 510(k)
Regulation Number
868.5160 FDA 510(k)FDA UDI
Market of Registration
Sweden EUDAMED
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

Yes

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

The Flow-i, Flow-c, and Flow-e Anesthesia Systems are gas-machine devices designed for the delivery of anesthesia gases and vapors during surgical procedures. These systems integrate precision flow control, vaporization, and monitoring to support patient ventilation and anesthetic administration in clinical settings.

These systems are intended for use in operating rooms and critical care environments, supplied as reusable medical devices. They comply with FDA 510(k) clearance and EU MDR regulations, with specific models authorized under the classification of Class II devices (868.5160). Each system variant (Flow-i, Flow-c, Flow-e) is engineered for compatibility with anesthesia workflows, featuring standardized interfaces and modular components for reliable performance.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Maquet Critical Care AB

Sources (3)

  • FDA 510(k) K191027 24 fields · synced Oct 6, 2026
  • FDA UDI 980a59b0-46d3-4599-84d8-7e619cc91637 33 fields · synced May 30, 2026
  • EUDAMED 80d59af2-bfab-487d-bfd5-cc61fb1d6d9b 61 fields · synced Jul 9, 2026