TOTALCARE., MODULAR THERAPY SYSTEM (MTS)— 510(k) K970636
Substantially EquivalentHill-Rom, Inc.
FDA 510(k) clearance K970636 for TOTALCARE., MODULAR THERAPY SYSTEM (MTS), Substantially Equivalent on 1997-08-26. Applicant: Hill-Rom, Inc.. Device class: 2.
Clearance details
- Applicant
- Hill-Rom, Inc.
- Product code
- Code IOQ
- Device class
- Class 2
- Regulation
- 21 CFR 890.5170
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Batesville, IN, US
Recent devices under product code IOQ
view allMore clearances from Hill-Rom, Inc.
view all- K260211 — Dashboard (P007000)
- K202018 — Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation
- K180079 — Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
- K013709 — HILL-ROM PRIMAVIEW MONITOR SYSTEM
- K973705 — CONTOR TABLE SURFACE
Adverse events under product code IOQ
product code IOQ- Malfunction
- 676
- Other
- 5
- Total
- 681
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 K970636
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 K970636.
Data sourced from openFDA. This site is unofficial and independent of the FDA.