BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT— 510(k) K924610
Substantially EquivalentEngineered Medical Systems
FDA 510(k) clearance K924610 for BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT, Substantially Equivalent on 1993-04-06. Applicant: Engineered Medical Systems. Device class: 2.
Clearance details
- Applicant
- Engineered Medical Systems
- Product code
- Code BTM
- Device class
- Class 2
- Regulation
- 21 CFR 868.5915
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code BTM
view allMore clearances from Engineered Medical Systems
view allAdverse events under product code BTM
product code BTM- Death
- 19
- Other
- 2
- Total
- 21
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 K924610
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 K924610.
Data sourced from openFDA. This site is unofficial and independent of the FDA.