AUGUSTINE INTUBATION GUIDE— 510(k) K954446
Substantially EquivalentAugustine Medical, Inc.
FDA 510(k) clearance K954446 for AUGUSTINE INTUBATION GUIDE, Substantially Equivalent on 1995-12-29. Applicant: Augustine Medical, Inc.. Device class: 1.
Clearance details
- Applicant
- Augustine Medical, Inc.
- Product code
- Code CCW
- Device class
- Class 1
- Regulation
- 21 CFR 868.5540
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
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- K001149 — AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
- K973741 — BAIR HUGGER BLOOD/FLUID WARMER
- K964673 — BAIR HUGGER MODEL 630 CARDIAC BLANKET
Adverse events under product code CCW
product code CCW- Death
- 31
- Injury
- 136
- Malfunction
- 3,703
- Other
- 1
- Total
- 3,871
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.