SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM— 510(k) K983648
Substantially EquivalentPerry Baromedical Services
FDA 510(k) clearance K983648 for SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM, Substantially Equivalent on 1999-02-24. Applicant: Perry Baromedical Services.
Clearance details
- Applicant
- Perry Baromedical Services
- Product code
- Code CBF
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Riviera Beach, FL, 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.