THERMAL REGULATION SYSTEM BLANKET— 510(k) K964377
Substantially EquivalentGibeck, Inc.
FDA 510(k) clearance K964377 for THERMAL REGULATION SYSTEM BLANKET, Substantially Equivalent on 1997-04-23. Applicant: Gibeck, Inc.. Device class: 2.
Clearance details
- Applicant
- Gibeck, Inc.
- Product code
- Code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code DWJ
view allMore clearances from Gibeck, Inc.
view all- K965016 — ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
- K964382 — HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)
- K960511 — GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET
- K954828 — ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT
- K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
Adverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
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.