ARTOCOOL-S WATER CIRCULATING COLD PACK
FDA 510(k) clearance K964354 · decided 1997-08-29
Clearance details
- K-number
- K964354
- Device name
- ARTOCOOL-S WATER CIRCULATING COLD PACK
- Applicant
- Ormed GmbH
- Decision
- Substantially Equivalent
- Date received
- 1996-10-31
- Decision date
- 1997-08-29
- Days to decision
- 302 days
- Clearance type
- Traditional
- Product code
- ILO
- Device class
- 2
- Regulation number
- 890.5720
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Concord, CA, US
- Third-party review
- No
- Expedited review
- No
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| BLEDSOE COLD CONTROL (K964710) | Med Technology, Inc. | 1997-05-09 |
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| STERILE SOFT-TEMP (K962983) | Adroit Medical Systems, Inc. | 1997-01-10 |
Recalls involving this device
No recalls on record reference this clearance.