DeviceClearance

K-1 INFANT TRANSPORT SYSTEM— 510(k) K895550

Substantially Equivalent

K-1 Medical Products, Inc.

FDA 510(k) clearance K895550 for K-1 INFANT TRANSPORT SYSTEM, Substantially Equivalent on 1989-12-07. Applicant: K-1 Medical Products, Inc.. Device class: 2.

Clearance details

Applicant
K-1 Medical Products, Inc.
Product code
Code FMZ
Device class
Class 2
Regulation
21 CFR 880.5400
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FMZ

product code FMZ
Death
2
Malfunction
457
Other
1
Total
460

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.