TZ SKULL PIN Adult— 510(k) K163322
Substantially EquivalentTz Medical, Inc.
FDA 510(k) clearance K163322 for TZ SKULL PIN Adult, Substantially Equivalent on 2017-02-23. Applicant: Tz Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Tz Medical, Inc.
- Product code
- Code HBL
- Device class
- Class 2
- Regulation
- 21 CFR 882.4460
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portland, OR, US
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More clearances from Tz Medical, Inc.
view all- K252772 — Arc Adjustable Radial Cuff Compression Device
- K173563 — ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE
- K102507 — AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
- K062577 — V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC
- K040208 — NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
Adverse events under product code HBL
product code HBL- Death
- 3
- Injury
- 753
- Malfunction
- 1,421
- Total
- 2,177
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.