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Table, Obstetric (And Accessories)

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
884.4900
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.4900 Obstetric table and accessories

§ 884.4900 Obstetric table and accessories.

(a) Identification. An obstetric table is a device with adjustable sections designed to support a patient in the various positions required during obstetric and gynecologic procedures. This generic type of device may include the following accessories: patient equipment, support attachments, and cabinets for warming instruments and disposing of wastes.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]

Table, Obstetric (And Accessories)

Page Type
Product Code
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
884.4900
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.4900 Obstetric table and accessories

§ 884.4900 Obstetric table and accessories.

(a) Identification. An obstetric table is a device with adjustable sections designed to support a patient in the various positions required during obstetric and gynecologic procedures. This generic type of device may include the following accessories: patient equipment, support attachments, and cabinets for warming instruments and disposing of wastes.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

[45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019]