Data / Medical devices / United States / Ambulatory Monitoring, Inc.
Ambulatory Monitoring, Inc.: FDA-registered device maker in Ardsley, NY, United States, 3 510(k) clearances
Ambulatory Monitoring, Inc. is registered with the FDA (registration 2430863) in Ardsley, NY, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 31, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2430863
- Address
- 731 Saw Mill River RD., Ardsley, NY, United States, 10502
- Owner or operator
- AMBULATORY MONITORING, INC. (2430863)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- November 30, 2007
- Registered through
- 2026
- Brand names listed
- Basic Respitrace System, Motionlogger Actigraph, Sleep Watch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Sleep Assessment | LEL | 2 | Specification developer | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 31, 2025 | K251574 | Sleep Watch | LEL | Substantially Equivalent | Ambulatory Monitoring, Inc. | accessdata.fda.gov |
| June 25, 1986 | K854030 | WRIST ACTIGRAPH | GWQ | Substantially Equivalent | Ambulatory Monitoring, Inc. | accessdata.fda.gov |
| January 26, 1978 | K772016 | RESPITRACE | BZK | Substantially Equivalent | Respitrace Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Spirometer, Monitoring (W/Wo Alarm)
- All makers of Device, Sleep Assessment
- All makers of Full-Montage Standard Electroencephalograph
Updated July 31, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.