PRESSURE MONITORING IV BOTTLE CAP— 510(k) K831867
Substantially EquivalentAlto Development Corp.
FDA 510(k) clearance K831867 for PRESSURE MONITORING IV BOTTLE CAP, Substantially Equivalent on 1983-08-12. Applicant: Alto Development Corp.. Device class: 2.
Clearance details
- Applicant
- Alto Development Corp.
- Product code
- Code DRS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2850
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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More clearances from Alto Development Corp.
view all- K964621 — A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON
- K932513 — LABELING FOR MYO/WIRE II STERNOTOMY SUTURES
- K931537 — A&E MEDICAL ELECTROSURG ELECTRO W/NON-STICK COAT
- K930528 — A&E MEDICAL ELECTROSURGICAL CONNECTING CORDS
- K914193 — A&E MEDICAL CORP DISPOS SUCT COAG W/NON STICK COAT
Adverse events under product code DRS
product code DRS- Death
- 8
- Malfunction
- 776
- Total
- 784
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.