MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307— 510(k) K060739

Substantially Equivalent

Khrunichev State Research & Production Space Centr

FDA 510(k) clearance K060739 for MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307, Substantially Equivalent on 2006-07-21. Applicant: Khrunichev State Research & Production Space Centr.

Clearance details

Applicant
Khrunichev State Research & Production Space Centr
Product code
Code CBF
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Deer Field, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code CBF

product code CBF
Death
6
Total
6

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.