510(k) K253569
- Device
- Atmo Gas Capsule System
- Applicant
- Atmo Biosciences, Ltd.
- 510(k) number
- K253569
- Product code
- NYV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-22
- Date received
- 2025-11-17
- Regulation
- 876.1725
- Classification name
- Gastrointestinal Motility System, Capsule
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Ian Macfarlane
- Address
- 436 Elgar Rd. Box Hill AU 3128 3128
FDA Registration Numbers#
- 3017496797
- 3027568582
- 9710107
- 3018094310
- 3016544248
Source Documents#
Other 510(k) Records For Product Code NYV#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250940 | Atmo Gas Capsule System | Atmo Biosciences, Ltd. | 2025-06-26 |
| K250493 | MotiliCap GI Monitoring System | Anx Robotica Corporation | 2025-05-21 |
| K092342 | SMARTPILL GI MONITORING SYSTEM, VERSION 2.0 | The Smartpill Corporation | 2009-10-30 |
| K053547 | SMARTPILL GI MONITORING SYSTEM | The Smartpill Corporation | 2006-07-18 |