BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM— 510(k) K011312
Substantially EquivalentKhrunichev State Research & Production Space Centr
FDA 510(k) clearance K011312 for BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM, Substantially Equivalent on 2001-07-18. 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
- Abbreviated
- Location
- San Antonio, TX, US
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.