Last synced on 12 July 2024 at 11:04 pm

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220917
510(k) Type
Traditional
Applicant
GRI-Alleset, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/18/2022
Days to Decision
49 days
Submission Type
Summary

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K220917
510(k) Type
Traditional
Applicant
GRI-Alleset, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/18/2022
Days to Decision
49 days
Submission Type
Summary