ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
FDA 510(k) clearance K991160 · decided 1999-09-02
Clearance details
- K-number
- K991160
- Device name
- ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
- Applicant
- Stihler Electronic GmbH
- Decision
- Substantially Equivalent
- Date received
- 1999-04-07
- Decision date
- 1999-09-02
- Days to decision
- 148 days
- Clearance type
- Abbreviated
- Product code
- BSB
- Device class
- 2
- Regulation number
- 864.9205
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Sound Beach, NY, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| THE BELMONT BUDDY LITE FLUID WARMER (K112639) | Belmont Instrument Corp. | 2011-11-16 |
| THE BELMONT BUDDY LITE FLUID WARMER (K090508) | Belmont Instrument Corp. | 2009-03-26 |
| BELMONT BUDDY PLUS FLUID WARMER (K062774) | Belmont Instrument Corp. | 2006-10-19 |
| BELMONT BUDDY FLUID WARMER (K052547) | Belmont Instrument Corp. | 2005-10-13 |
| MICROHEATER (K031478) | Belmont Instrument Corp. | 2003-07-02 |
| ASTOFLO (K020060) | Nats Corp. | 2002-03-05 |
| MODIFICATION TO THERMAL ANGEL (K012031) | Estill Medical Technologies, Inc. | 2001-07-26 |
| PRISMATHERM II, ASTOLINE (K991159) | Stihler Electronic GmbH | 1999-09-03 |
| THERMAL ANGEL (K984640) | Estill Medical Technologies, Inc. | 1999-07-01 |
| BAIR HUGGER BLOOD/FLUID WARMER (K973741) | Augustine Medical, Inc. | 1998-04-30 |
| THERMACYL BLOOD/FLUID WARMER (K953741) | Baxter Healthcare Corp | 1996-06-26 |
| BLOOD/FLUID WARMER MODEL DW-1000A (K770232) | Gorman Rupp Industries | 1977-02-14 |
Recalls involving this device
No recalls on record reference this clearance.