PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE— 510(k) K974387
Substantially EquivalentMicrowave Medical Systems, Inc.
FDA 510(k) clearance K974387 for PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE, Substantially Equivalent on 1999-09-01. Applicant: Microwave Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Microwave Medical Systems, Inc.
- Product code
- Code KDJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.5630
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Acton, MA, US
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More clearances from Microwave Medical Systems, Inc.
view allAdverse events under product code KDJ
product code KDJ- Death
- 298
- Injury
- 9,221
- Malfunction
- 8,438
- Other
- 1
- Total
- 17,958
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.