CPR MASK— 510(k) K083418
Substantially EquivalentFirstar Healthcare Co., Ltd.
FDA 510(k) clearance K083418 for CPR MASK, Substantially Equivalent on 2010-07-22. Applicant: Firstar Healthcare Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Firstar Healthcare Co., Ltd.
- Product code
- Code CBP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5870
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dover, DE, US
Recent devices under product code CBP
view allRecalls naming K083418
K-number listed on FDA's recall record- Z-2132-2016 — Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. UPC Red color kit: 845174005464; UPC Lime color kit: 845174005594; UPC Purple color: 845174005600; UPC of master case of 6 845174005471 (2 each color) Item # 4037, Outfitter First Aid Kit, CPR shield with one way valve & barrier filter, brand Lifeline, UPC 845174003453
- Z-2133-2016 — 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083418.
Data sourced from openFDA. This site is unofficial and independent of the FDA.