Gibeck, Inc.
Indianapolis, IN, US
Gibeck, Inc. appears in FDA device records in Indianapolis, IN. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Gibeck, Inc. between 1990 and 1997. The busiest year on record is 1995, with 7. The most recent is 1997, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 2 |
| 1992 | 1 |
| 1995 | 7 |
| 1996 | 1 |
| 1997 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K965016 | ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) | CAH | Substantially Equivalent | |
| K964377 | THERMAL REGULATION SYSTEM BLANKET | DWJ | Substantially Equivalent | |
| K964382 | HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) | CAH | Substantially Equivalent | |
| K960511 | GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET | DWJ | Substantially Equivalent | |
| K954828 | ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORT | CAH | Substantially Equivalent | |
| K953544 | HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT | BYD | Substantially Equivalent | |
| K953491 | HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE | BYD | Substantially Equivalent | |
| K952845 | HUMID-VENT TRACH-VENT | BYD | Substantially Equivalent | |
| K952844 | HUMID-VENT 2 | BYD | Substantially Equivalent | |
| K952750 | HUMID-VENT 1 | BYD | Substantially Equivalent | |
| K952084 | HUMID-VENT FILTER PEDI | BYD | Substantially Equivalent | |
| K951856 | HUMID-VENT MICRO | BYD | Substantially Equivalent | |
| K914747 | XENON CIRCUIT | IYT | Substantially Equivalent | |
| K900979 | GAS SAMPLING NASAL CANNULA | CCK | Substantially Equivalent | |
| K897171 | DISPOSABLE CO2 ABSORBER/E | CBL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain