Infosend Gsm
by Fisher & Paykel Healthcare, Inc.
510(k) K110316
Infosend Gsm is a Class II device made by Fisher & Paykel Healthcare, Inc., cleared under FDA 510(k) K110316 on 19 Aug 2011, 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 | NumberK110316 | Date19 Aug 2011 | StatusActive |
Official records
- FDA 510(k) database K110316
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BZD
- FDA applicant
- Fisher & Paykel Healthcare, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5905
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K110316
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Fisher & Paykel Healthcare 900ICON500N | 900ICON500N / 900ICON500N | 09420012425218 | On the market | |
| Fisher & Paykel Healthcare Infosmart_web | Infosmart_web / Infosmart_web | 09420012448019 | On the market |
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