Submission Details
| 510(k) Number | K043517 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 2004 |
| Decision Date | February 03, 2005 |
| Days to Decision | 45 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Abbreviated
TRANSMITTER, ZS-940PA SERIES
Feb 2005
Decision
45d
Days
Class 2
Risk
About This 510(k) Submission
K043517 is an FDA 510(k) clearance for the TRANSMITTER, ZS-940PA SERIES, a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT), submitted by Nihon Kohden America, Inc. (Foothill Ranch, US). The FDA issued a Cleared decision on February 3, 2005, 45 days after receiving the submission on December 20, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.
Device Classification
| Product Code | DRT — Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.2300 |
Manufacturer
Similar Devices — DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
All 337
K252676 · Circadia Health, Inc.
· Feb 2026
K253388 · Sleepiz AG
· Jan 2026
K251364 · Sleepiz AG
· Jul 2025
K234003 · Circadia Technologies, Ltd.
· May 2024
K232354 · Murata Vios, Inc.
· Mar 2024
K231733 · Neteera Technologies , Ltd.
· Feb 2024
More from Nihon Kohden America, Inc.
View all
K113117
· GWQ · Mar 2012
K120485
· OMA · Mar 2012
K092573
· OMA · Jul 2010
K083456
· CCK · Mar 2009
K083271
· MHX · Dec 2008