Leap Frog
by Philips Medical Systems (Cleveland), Inc.
510(k) K834211
Leap Frog is a Class II device made by Philips Medical Systems (Cleveland), Inc., cleared under FDA 510(k) K834211 on 5 Jun 1984, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK834211 | Date5 Jun 1984 | StatusActive |
Official records
- FDA 510(k) database K834211
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DSI
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code DSI (Detector And Alarm, Arrhythmia).
- SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM by SIEMENS MEDICAL SOLUTIONS USA, INC.
- FUKUDA DENSHI MODEL DS-3300 ETR by FUKUDA DENSHI USA, INC.
- MEDILOG 4500 SYSTEM by Oxford Medilog, Inc.
- AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR by Agilent Technologies, Inc.
- AEGIS AMBULATORY MONITORING SYSTEM by Aegis Medical Systems, Inc.
- MEDILOG M3 by Oxford Medilog, Inc.
- OHMEDA MODULUS CD ANESTHESIA SYSTEM WITH C.V. by Ohmeda Medical
- SPACELABS ARRHYTHMIA NET (TM) LEVEL 2 by Spacelabs, Inc.
- FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR by FUKUDA DENSHI USA, INC.
- MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM by Medicalgorithmics S.A.
Other devices from Philips Medical Systems (Cleveland), Inc.
See all devices from Philips Medical Systems (Cleveland), Inc. →