PULSE-AID DEVICE
FDA 510(k) clearance K843977 · decided 1985-02-01
Clearance details
- K-number
- K843977
- Device name
- PULSE-AID DEVICE
- Applicant
- James J. Lally
- Decision
- Substantially Equivalent
- Date received
- 1984-10-05
- Decision date
- 1985-02-01
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- LIX
- Device class
- 2
- Regulation number
- 870.5210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Kansas City, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
| CPR BAND (K201581) | Credo | 2021-03-06 |
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| Reusable Full Silicone Cover (K151702) | Laerdal Medical AS | 2015-08-13 |
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| TRUECPR COACHING DEVICE (K123597) | Physio-Control, Inc. | 2013-04-17 |
| CPRMETER CPR FEEDBACK DEVICE (K122050) | Laerdal Medical A/S | 2012-10-22 |
| POCKETCPR (K112660) | Zoll Medical Corp | 2012-05-10 |
| RHYTHM OF LIFE, MODEL R0901-05 (K092408) | Rapid Response Solutions, LLC | 2009-10-14 |
| POCKETCPR (K071321) | Bio-Detek, Inc. | 2007-09-12 |
| MODIFICATION TO THE GRIP (K010526) | Elcare Innovations, Inc. | 2001-12-13 |
| CPR EZY MASK AND PAD (K003937) | Medteq Innovations Pty, Ltd. | 2001-06-06 |
Recalls involving this device
No recalls on record reference this clearance.