HDM97
FDA 510(k) clearance K020908 · decided 2002-05-22
Clearance details
- K-number
- K020908
- Device name
- HDM97
- Applicant
- Ibp Instruments GmbH
- Decision
- Substantially Equivalent
- Date received
- 2002-03-20
- Decision date
- 2002-05-22
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- FIZ
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hannover, DE
- Third-party review
- Yes
- Expedited review
- No
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| NEO-STAT DIALYSATE METER (K920810) | Automata Medical Instrumentation, Inc. | 1993-01-15 |
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| COLORADO MEDICAL MODEL CTM-3000 (K853735) | Colorado Medical, Inc. | 1985-10-04 |
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Recalls involving this device
No recalls on record reference this clearance.