HEAD STRAP
FDA 510(k) clearance K831008 · decided 1983-05-09
Clearance details
- K-number
- K831008
- Device name
- HEAD STRAP
- Applicant
- Medovations, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-30
- Decision date
- 1983-05-09
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- BTK
- Device class
- 1
- Regulation number
- 868.5560
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, 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.
| Record | Firm | Date |
|---|---|---|
| GENERAL ANESTHESIA SYSTEM (K944949) | Vital Signs, Inc. | 1994-11-14 |
| STRAP, HEAD, GAS MASK (K914335) | Vital Signs, Inc. | 1992-04-02 |
| HEADSTRAP (K854537) | Life Design Systems, Inc. | 1985-12-03 |
| MEDIPART FACE MASK HEADSTRAP MP-9100 (K853573) | Medipart Jerry Alexander | 1985-10-29 |
| HEADSTRAP (K810991) | Respironics, Inc. | 1981-04-29 |
Recalls involving this device
No recalls on record reference this clearance.