Acu-Halt
FDA 510(k) K945374 · Eva-Health USA, Inc.
510(k) numberK945374
Submission
- Device name
- Acu-Halt
- Applicant
- Eva-Health USA, Inc.
Staten Island, NY, US - Received
- November 2, 1994
- Decision date
- August 9, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
No product code recorded.
Other 510(k)s with product code LDQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993797 | EC-7701 Fluid Warming CabinetLDQ · Traditional | Enthermics Medical Systems, Inc. | 01/20/2000SE |
| K992258 | Hot Shot Fluid Warmer IV FluidsLDQ · Traditional | Infra-Med Technologies, Inc. | 01/12/2000SE |
| K981032 | Piv SystemLDQ · Traditional | Medical Solutions, Inc. | 09/02/1998SE |
| K973747 | Controlled Temperature Cabinet SystemLDQ · Traditional | Smith | 05/07/1998SE |
| K955661 | Acu-HaltLDQ · Traditional | Glederer & Co., Inc. | 12/30/1996SE |
| K955776 | Acu-LabLDQ · Traditional | Glederer & Co., Inc. | 06/05/1996SE |
| K944961 | Personal Alarm System (Pas)LDQ · Traditional | Cytoprobe Corp. | 08/07/1995SE |
| K942810 | Palco Labs Cold PouchLDQ · Traditional | Palco Laboratories, Inc. | 06/28/1995SE |
| K930884 | Medical Procedure Tray, ModificationLDQ · Traditional | Enpak Medical Corp. | 03/21/1995SE |
| K934703 | Medicool ProtectallLDQ · Traditional | Avc Regulatory Compliance/Technical Services | 01/26/1994SE |
Questions and answers
When was Acu-Halt cleared by the FDA?
Acu-Halt (K945374) received a 510(k) decision of Substantially Equivalent on August 9, 1995, 280 days after the submission was received.