CONDUCER HEAT EXCHANGER— 510(k) K923311

Substantially Equivalent

3M Health Care, Sarns

FDA 510(k) clearance K923311 for CONDUCER HEAT EXCHANGER, Substantially Equivalent on 1992-09-18. Applicant: 3M Health Care, Sarns. Device class: 2.

Clearance details

Applicant
3M Health Care, Sarns
Product code
Code DTR
Device class
Class 2
Regulation
21 CFR 870.4240
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ann Arbor, MI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DTR

product code DTR
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.