FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

STROLLER SPRINT

K Number: K841808 · Decision May 16, 1984
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
54
Applicant Total
6
Review Days
15

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Basic Information

Device Name
STROLLER SPRINT
K Number
K841808
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.5655
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Cryogenic Assoc.
Date Received
May 1, 1984
Decision Date
May 16, 1984
Product Code
BYJ
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
BYJ Unit, Liquid-Oxygen, Portable

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (BYJ), ordered by most recent decision date.

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Other Clearances by Cryogenic Assoc.

K Number Device Name
K883590 OXYTROL
K852663 PORTABLE GASEOUS OXGYEN CONTAINER
K822789 ROOMATE II
K801104 ROOMMATE-OXYGEN CONCENTRATOR
K800742 LIBERATOR/STROLLER II SYSTEM