SLEEP APNEA NASAL CPAP SYSTEM— 510(k) K871693
Substantially EquivalentPuritan Bennett Corp.
FDA 510(k) clearance K871693 for SLEEP APNEA NASAL CPAP SYSTEM, Substantially Equivalent on 1987-09-15. Applicant: Puritan Bennett Corp.. Device class: 2.
Clearance details
- Applicant
- Puritan Bennett Corp.
- Product code
- Code BYE
- Device class
- Class 2
- Regulation
- 21 CFR 868.5965
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Overland Park, KS, US
Recent devices under product code BYE
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- K001646 — PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
Adverse events under product code BYE
product code BYE- Death
- 5
- Total
- 5
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.