ABBY II PATIENT MONITOR OR VITAL SIGNS M— 510(k) K801515
Substantially EquivalentAbbott Medical Electronics Co.
FDA 510(k) clearance K801515 for ABBY II PATIENT MONITOR OR VITAL SIGNS M, Substantially Equivalent on 1980-07-08. Applicant: Abbott Medical Electronics Co.. Device class: 2.
Clearance details
- Applicant
- Abbott Medical Electronics Co.
- Product code
- Code DRT
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Worth, TX, US
Recent devices under product code DRT
view allMore clearances from Abbott Medical Electronics Co.
view allAdverse events under product code DRT
product code DRT- Death
- 4
- Total
- 4
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.