ALPHA-I— 510(k) K832642
Substantially EquivalentJohnson Flexgroup
FDA 510(k) clearance K832642 for ALPHA-I, Substantially Equivalent on 1983-11-21. Applicant: Johnson Flexgroup. Device class: 1.
Clearance details
- Applicant
- Johnson Flexgroup
- Product code
- Code LHC
- Device class
- Class 1
- Regulation
- 21 CFR 890.5950
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code LHC
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- K152522 — ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes
- K150190 — IntraTemp Solution Warmer
- K142173 — NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE
- K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
Data sourced from openFDA. This site is unofficial and independent of the FDA.