RECON 1— 510(k) K812128
Substantially EquivalentPrecision Metering, Inc.
FDA 510(k) clearance K812128 for RECON 1, Substantially Equivalent on 1981-08-18. Applicant: Precision Metering, Inc.. Device class: 1.
Clearance details
- Applicant
- Precision Metering, Inc.
- Product code
- Code CAX
- Device class
- Class 1
- Regulation
- 21 CFR 868.2340
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CAX
view allMore clearances from Precision Metering, Inc.
view allAdverse events under product code CAX
product code CAX- Death
- 3
- Other
- 1
- 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.