Atlas FDA

PHILIPS EASYVISION

FDA 510(k) clearance K952704 · decided 1995-07-03

Clearance details

K-number
K952704
Device name
PHILIPS EASYVISION
Applicant
Philips Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
1995-06-14
Decision date
1995-07-03
Days to decision
19 days
Clearance type
Traditional
Product code
IZI
Device class
2
Regulation number
892.1600
Medical specialty
Radiology
Advisory committee
Radiology
Location
Shelton, CT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (P160029/S028)Philips Medical Systems, Inc.2025-06-20
HeartStart Home Defibrillator (M5068A) and HeartStart Onsite Defibrillator (M5066A) (P160029/S027)Philips Medical Systems, Inc.2025-06-09
HeartStart FR3 Defibrillator (P160028/S006)Philips Medical Systems, Inc.2025-05-09
HeartStart Home Defibrillator, HeartStart OnSite Defibrillator, HeartStart HS1 SMART Pads, Adult (M5071A), HeartStart HS (P160029/S026)Philips Medical Systems, Inc.2024-12-12
HeartStart FR3 Primary Battery (989803150161) (P160028/S005)Philips Medical Systems, Inc.2024-09-11
HeartStart HS1 Onsite Defibrillator (M5066A), HeartStart HS1 Home Defibrillator (M5068A) (P160029/S024)Philips Medical Systems, Inc.2024-02-21
HeartStart OnSite Defibrillator, HeartStart Home Defibrillator, HeartStart HS1 SMART Pads, Adult, HeartStart HS1 SMART P (P160029/S022)Philips Medical Systems, Inc.2024-01-23
HeartStart OnSite Defibrillator and HeartStart Home Defibrillator (P160029/S023)Philips Medical Systems, Inc.2024-01-05