Cp&S Instant Cold Pack Limb Kit Transporter
FDA 510(k) K974190 · Consolidated Products & Services, Inc.
510(k) numberK974190
Submission
- Device name
- Cp&S Instant Cold Pack Limb Kit Transporter
- Applicant
- Consolidated Products & Services, Inc.
Braintree, MA, US - Received
- November 4, 1997
- Decision date
- November 19, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IMD – Pack, Hot Or Cold, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5710
- Specialty
- Physical Medicine
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More from Allegiance Healthcare Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K930759 | CP & S Sterile Burn SheetFPY · Traditional | 01/21/1994SE |
| K890551 | Urinary Drainage UnitKNX · Traditional | 02/28/1989SE |
| K890550 | Cp&S Disposable Urinary Legbag (Medium & Large)KNX · Traditional | 02/28/1989SE |
| K890552 | Cp&S Gavage Constainer, DisposableKNT · Traditional | 02/24/1989SE |
| K890554 | Cp&S Disposable Instant Super Hot CompressIMD · Traditional | 02/13/1989SE |
| K890553 | Cp&S Disposable Instant Cold CompressIMD · Traditional | 02/13/1989SE |
Questions and answers
When was Cp&S Instant Cold Pack Limb Kit Transporter cleared by the FDA?
Cp&S Instant Cold Pack Limb Kit Transporter (K974190) received a 510(k) decision of Substantially Equivalent on November 19, 1997, 15 days after the submission was received.
What is the product code of K974190?
The FDA product code is IMD – Pack, Hot Or Cold, Disposable, a Class I (low risk) device regulated under 21 CFR 890.5710.