Atlas FDA

PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR

FDA 510(k) clearance K030038 · decided 2003-03-12

Clearance details

K-number
K030038
Device name
PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR
Applicant
Philips Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2003-01-06
Decision date
2003-03-12
Days to decision
65 days
Clearance type
Special
Product code
MHX
Device class
2
Regulation number
870.1025
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Andover, MA, 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 FR3 Text (861388) Defibrillator; HeartStart FR3 ECG (861389) Defibrillator (P160028/S007)Philips Medical Systems, Inc.2026-05-21
HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (P160029/S029)Philips Medical Systems, Inc.2026-02-02
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