FDA Device Intelligence
Home › BEDFONT SCIENTIFIC LIMITED › Smokerlyzer

Smokerlyzer

BEDFONT SCIENTIFIC LIMITED · Model Micro+ · UDI-DI 05060246860047

CCJ Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
12
Facilities

Description

The Micro+™ Smokerlyzer® product is a breath carbon monoxide monitor intended for multi-patient use by healthcare professionals in smoking cessation programmes and research. The Micro+™ Smokerlyzer® product can also be used as an indicator of carbon monoxide poisoning in a healthcare environment.

Recalls

DateFirmReason
2025-04-21Capnia IncSampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.