510(k) K822316
- Device
- HEART MONITOR BRACELET ALARM
- Applicant
- HMBA
- 510(k) number
- K822316
- Product code
- DRI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-09-21
- Date received
- 1982-08-03
- Regulation
- 870.2620
- Classification name
- Monitor, Line Isolation
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9611102
- 3015910259
- 3018269545
- 3015173212
- 1054241
- 1043214
- 1055236
- 3016761372
- 1319639
- 3006536657
- 3014499739
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DRI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K902492 | CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S | Datex Division Instrumentarium Corp. | 1990-07-06 |
| K902493 | CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR | Datex Division Instrumentarium Corp. | 1990-07-06 |
| K802326 | PRESSURE MONITORING LINES | Stanco Medical, Inc. | 1980-10-10 |
Legacy Summary#
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FDA Review#
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