Handypack 911SC
FDA 510(k) K944541 · Pace Tech, Inc.
510(k) numberK944541
Submission
- Device name
- Handypack 911SC
- Applicant
- Pace Tech, Inc.
Clearwater, FL, US - Received
- September 15, 1994
- Decision date
- February 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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More from Southmedic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K951226 | Vitalmax 4000/MINIPACK 3100/3000DSK · Traditional | 11/21/1996SE |
| K953795 | Vitalmax 4100CBS · Traditional | 07/01/1996SE |
| K945385 | Vitalmax 800 Plus/Vitalmax 810 Plus/Minipack 300MHX · Traditional | 01/31/1995SE |
| K925701 | Minipack 911-STCCCK · Traditional | 08/11/1994SE |
| K934385 | Minipack 3100/3000 ModificationDXN · Traditional | 08/10/1994SE |
| K933624 | Vitalmax 4000MHX · Traditional | 07/19/1994SE |
| K930559 | Vitalmax 800-CCCK · Traditional | 09/03/1993SE |
| K912835 | Mini-Pack 911 SeriesMHX · Traditional | 02/03/1992SE |
| K912880 | Vitalmax 510/520DQA · Traditional | 11/14/1991SE |
| K913263 | Vitalmax 830 SeriesMHX · Traditional | 10/10/1991SE |
Questions and answers
When was Handypack 911SC cleared by the FDA?
Handypack 911SC (K944541) received a 510(k) decision of Substantially Equivalent on February 22, 1995, 160 days after the submission was received.
What is the product code of K944541?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.