Heart Monitor Bracelet Alarm
FDA 510(k) K822316 · Hmba
510(k) numberK822316
Submission
- Device name
- Heart Monitor Bracelet Alarm
- Applicant
- Hmba
Mchenry, IL, US - Received
- August 3, 1982
- Decision date
- September 21, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRI – Monitor, Line Isolation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.2620
- Specialty
- Cardiovascular
Other 510(k)s with product code DRI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K902493 | Cardiocap II CG-2GS, 2G, 1GS, 1G, 2CG, CS MonitorDRI · Traditional | Datex Division Instrumentarium Corp. | 07/06/1990SE |
| K902492 | Cardiocap II Monitors: CH, CH-2, Ch-S, CH-2SDRI · Traditional | Datex Division Instrumentarium Corp. | 07/06/1990SE |
| K802326 | Pressure Monitoring LinesDRI · Traditional | Stanco Medical, Inc. | 10/10/1980SE |
Questions and answers
When was Heart Monitor Bracelet Alarm cleared by the FDA?
Heart Monitor Bracelet Alarm (K822316) received a 510(k) decision of Substantially Equivalent on September 21, 1982, 49 days after the submission was received.
What is the product code of K822316?
The FDA product code is DRI – Monitor, Line Isolation, a Class I (low risk) device regulated under 21 CFR 870.2620.