MODULAR
FDA 510(k) clearance K001988 · decided 2001-02-05
Clearance details
- K-number
- K001988
- Device name
- MODULAR
- Applicant
- Heyer America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-06-29
- Decision date
- 2001-02-05
- Days to decision
- 221 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Appollo Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Anestar and Anestar Plus Anesthesia System. recall (Z-0929-06) | Datascope Corp | 2006-06-02 |