PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT— 510(k) K881141
Substantially EquivalentBaxter Healthcare Corp
FDA 510(k) clearance K881141 for PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT, Substantially Equivalent on 1988-04-25. Applicant: Baxter Healthcare Corp. Device class: 1.
Clearance details
- Applicant
- Baxter Healthcare Corp
- Product code
- Code CAI
- Device class
- Class 1
- Regulation
- 21 CFR 868.5240
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Valencia, CA, US
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Adverse events under product code CAI
product code CAI- Malfunction
- 869
- Other
- 1
- Total
- 870
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.