PRECISION MEDICAL OXYGEN REGULATOR— 510(k) K901831
Substantially EquivalentPrecision Medical, Inc.
FDA 510(k) clearance K901831 for PRECISION MEDICAL OXYGEN REGULATOR, Substantially Equivalent on 1990-08-14. Applicant: Precision Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Precision Medical, Inc.
- Product code
- Code CAN
- Device class
- Class 1
- Regulation
- 21 CFR 868.2700
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northampton, PA, US
Recent devices under product code CAN
view allMore clearances from Precision Medical, Inc.
view allAdverse events under product code CAN
product code CAN- Death
- 4
- Other
- 1
- 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 →
Recalls naming K901831
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K901831.
Data sourced from openFDA. This site is unofficial and independent of the FDA.