AVIA PAIN MEDICATION DELIVERY SYSTEM— 510(k) K990312
Substantially EquivalentAmtec Medical
FDA 510(k) clearance K990312 for AVIA PAIN MEDICATION DELIVERY SYSTEM, Substantially Equivalent on 1999-04-22. Applicant: Amtec Medical. Device class: 2.
Clearance details
- Applicant
- Amtec Medical
- Product code
- Code MEA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code MEA
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- K170982 — CADD®- Solis Ambulatory Infusion Pump with Wireless Communication +4 more
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- K130394 — CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
- K092313 — PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
Adverse events under product code MEA
product code MEA- Death
- 19
- Malfunction
- 25,089
- Total
- 25,108
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.