AMBULATORY X-12 TELEMETRY MODULE— 510(k) K974149
Substantially EquivalentMortara Instrument, Inc.
FDA 510(k) clearance K974149 for AMBULATORY X-12 TELEMETRY MODULE, Substantially Equivalent on 1998-01-08. Applicant: Mortara Instrument, Inc.. Device class: 2.
Clearance details
- Applicant
- Mortara Instrument, Inc.
- Product code
- Code DRG
- Device class
- Class 2
- Regulation
- 21 CFR 870.2910
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milwaukee, WI, US
Recent devices under product code DRG
view allMore clearances from Mortara Instrument, Inc.
view allAdverse events under product code DRG
product code DRG- Death
- 5
- 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 K974149
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 K974149.
Data sourced from openFDA. This site is unofficial and independent of the FDA.