AERO PULSE ALTERNATING PRES. PUMP— 510(k) K771463
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K771463 for AERO PULSE ALTERNATING PRES. PUMP, Substantially Equivalent on 1977-08-26. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, Inc.
- Product code
- Code FNM
- Device class
- Class 2
- Regulation
- 21 CFR 880.5550
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code FNM
product code FNM- Death
- 22
- Injury
- 349
- Other
- 4
- Total
- 375
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.